Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04647110
Collaborator
(none)
549
1
3
183.6

Study Details

Study Description

Brief Summary

This study aims to explore for the first time how the different ALK TKIs have been sequenced in real-world clinical practice and with which outcomes for Swedish lung cancer patients

Study Design

Study Type:
Observational
Actual Enrollment :
549 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Real-world Study of Non-small Cell Lung Cancer Treatment With ALK-tyrosine Kinase Inhibitors (ALK TKI) in Sweden: Drug Sequencing, Treatment Duration and Overall Survival - A Retrospective Study Using Swedish Register Data
Actual Study Start Date :
Dec 14, 2020
Actual Primary Completion Date :
Mar 15, 2021
Actual Study Completion Date :
Mar 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Swedish Anaplastic lymphoma kinase (ALK) positive Non-small cell lung cancer (NSCLC) patients

Drug: crizotinib
as provided in real world practice

Drug: alectinib
as provided in real world practice

Drug: brigatinib
as provided in real world practice

Drug: ceritinib
as provided in real world practice

Drug: lorlatinib
as provided in real world practice

Outcome Measures

Primary Outcome Measures

  1. Overall Survival (OS): Based on Treatment Cohort Groups [From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. Results were reported for treatment cohort groups based on generation of ALK treatment and were as following: Group A1 = chemotherapy + crizotinib (first generation ALK TKI) + any second (2nd) generation ALK TKI; Group A2 = crizotinib + any 2nd generation ALK TKI; Group B1: chemotherapy + crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group B2 = crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group C1 = chemotherapy + crizotinib + any 2nd generation ALK TKI + lorlatinib (third generation ALK TKI); Group C2: crizotinib + any 2nd generation ALK TKI + lorlatinib and Group D1 = any 2nd generation ALK TKI + any other 2nd generation ALK TKI.

  2. Overall Survival: Based on Chemotherapy Status [From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. Results were reported based on chemotherapy status.

  3. Overall Survival: Based on Central Nervous System (CNS) Metastases Status [From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure, participants were grouped on basis of their CNS-metastases status.

  4. Overall Survival: Based on ALK Sequencing, 1 Line of ALK TKI Treatment [From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure, OS was reported for participants who received 1 line of ALK TKI treatment. Reporting arms were based on type of ALK TKI, with or without chemotherapy. ALK TKIs considered were crizotinib, alectinib, ceritinib.

  5. Overall Survival: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment [From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure OS was reported for participants who received 2 lines of ALK TKI treatment. Reporting arms were based on type of first line ALK TKI treatment and second line of ALK TKI treatment, with or without chemotherapy.

  6. Overall Survival: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment [From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure OS was reported for participants who received 3 lines of ALK inhibitor treatment. Reporting arms were based on type of first line ALK TKI treatment, second line of ALK TKI treatment and third line of ALK TKI treatment with or without, chemotherapy.

  7. Overall Survival: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment [From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure, OS was reported for participants who received >=4 lines of ALK inhibitor treatment with or without chemotherapy.

  8. Percentage of Participants Alive After 5 Years From Index Date: Based on Treatment Cohort Groups [5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Results were reported for treatment cohort groups based on generation of ALK treatment and were as following: Group A1 = chemotherapy + crizotinib (first generation ALK TKI) + any second (2nd) generation ALK TKI; Group A2 = crizotinib + any 2nd generation ALK TKI; Group B1: chemotherapy + crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group B2 = crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group C1 = chemotherapy + crizotinib + any 2nd generation ALK TKI + lorlatinib (third generation ALK TKI); Group C2: crizotinib + any 2nd generation ALK TKI + lorlatinib and Group D1 = any 2nd generation ALK TKI + any other 2nd generation ALK TKI.

  9. Percentage of Participants Alive After 5 Years From Index Date: Based on Chemotherapy Status [5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on chemotherapy status.

  10. Percentage of Participants Alive After 5 Years From Index Date: Based on CNS Metastases Status [5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on CNS metastases status.

  11. Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 1 Line of ALK TKI Treatment [5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 1 line of ALK TKI treatment, were reported. Reporting arms were based on type of first line ALK TKI treatment, with or without chemotherapy. ALK TKIs considered were crizotinib, alectinib, ceritinib.

  12. Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment [5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 2 lines of ALK TKI treatment, were reported. Reporting arms were based on type of first line ALK TKI treatment and second line of ALK TKI treatment, with or without chemotherapy.

  13. Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment [5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 3 lines of ALK TKI treatment. Reporting arms were based on type of first line ALK TKI treatment, second line of ALK TKI treatment, and third line of ALK TKI treatment, with or without chemotherapy.

  14. Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment [5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, data is reported for participants who received >=4 lines of ALK inhibitor treatment with or without chemotherapy.

  15. Percentage of Participants Alive After 6 Years From Index Date: Based on Treatment Cohort Groups [6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Results were reported for treatment cohort groups based on generation of ALK treatment and were as following: Group A1 = chemotherapy + crizotinib (first generation ALK TKI) + any second (2nd) generation ALK TKI; Group A2 = crizotinib + any 2nd generation ALK TKI; Group B1: chemotherapy + crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group B2 = crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group C1 = chemotherapy + crizotinib + any 2nd generation ALK TKI + lorlatinib (third generation ALK TKI); Group C2: crizotinib + any 2nd generation ALK TKI + lorlatinib and Group D1 = any 2nd generation ALK TKI + any other 2nd generation ALK TKI.

  16. Percentage of Participants Alive After 6 Years From Index Date: Based on Chemotherapy Status [6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on chemotherapy status.

  17. Percentage of Participants Alive After 6 Years From Index Date: Based on CNS Metastases Status [6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on CNS metastases status.

  18. Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 1 Line of ALK TKI Treatment [6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 1 line of ALK TKI treatment, were reported. Reporting arms were based on type of first line ALK TKI treatment, with or without chemotherapy. ALK TKIs considered were crizotinib, alectinib, ceritinib.

  19. Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment [6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 2 lines of ALK TKI treatment, were reported. Reporting arms were based on type of first line ALK TKI treatment and second line of ALK TKI treatment, with or without chemotherapy.

  20. Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment [6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure OS was reported for participants who received 3 lines of ALK inhibitor treatment. Reporting arms were based on type of first line ALK TKI treatment, second line of ALK TKI treatment, and third line of ALK TKI treatment, with or without chemotherapy.

  21. Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment [6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, data is reported for participants who received >=4 lines of ALK inhibitor treatment with or without chemotherapy.

Secondary Outcome Measures

  1. Duration of Treatment: Based on Treatment Cohort Groups [From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Duration of treatment was defined as number of days on treatment calculated based on pharmaceutical specialties in Sweden (FASS) recommended dose for filled prescriptions of ALK-inhibitors taking permissible gap and stockpiling into account. Results were reported for treatment cohort groups based on generation of ALK treatment and were as following: Group A1 = chemotherapy + crizotinib (first generation ALK TKI) + any second (2nd) generation ALK TKI; Group A2 = crizotinib + any 2nd generation ALK TKI; Group B1: chemotherapy + crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group B2 = crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group C1 = chemotherapy + crizotinib + any 2nd generation ALK TKI + lorlatinib (third generation ALK TKI); Group C2: crizotinib + any 2nd generation ALK TKI + lorlatinib and Group D1 = any 2nd generation ALK TKI + any other 2nd generation ALK TKI.

  2. Duration of Treatment: Based on Chemotherapy Status [From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Duration of treatment was defined as number of days on treatment calculated based on pharmaceutical specialties in Sweden (FASS) recommended dose for filled prescriptions of ALK-inhibitors taking permissible gap and stockpiling into account. Results were reported based on chemotherapy status.

  3. Duration of Treatment: Based on ALK Sequencing, 1 Line of ALK TKI Treatment [From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Duration of treatment was defined as number of days on treatment calculated based on FASS recommended dose for filled prescriptions of ALK-inhibitors taking permissible gap and stockpiling into account. Reporting arms were based on type of ALK TKI, with or without chemotherapy. ALK TKIs considered were crizotinib, alectinib, ceritinib.

  4. Duration of Treatment: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment [From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Duration of treatment was defined as number of days on treatment calculated based on FASS recommended dose for filled prescriptions of ALK-inhibitors taking permissible gap and stockpiling into account. Reporting arms were based on type of first line ALK TKI treatment, and second line of ALK TKI treatment, with or without chemotherapy.

  5. Duration of Treatment: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment [From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Duration of treatment was defined as number of days on treatment calculated based on FASS recommended dose for filled prescriptions of ALK-inhibitors taking permissible gap and stockpiling into account. Reporting arms were based on type of first line ALK TKI treatment, second line of ALK TKI treatment, and third line of ALK TKI treatment with or without chemotherapy.

  6. Duration of Treatment: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment [From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)]

    Duration of treatment was defined as number of days on treatment calculated based on FASS recommended dose for filled prescriptions of ALK-inhibitors taking permissible gap and stockpiling into account. In this outcome measure, duration of treatment was reported for participants who received >=4 lines of ALK inhibitor treatment, with or without chemotherapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

-Inclusion criteria for ALK-positive NSCLC patients will be based on prescription data i.e. defines eligible patients as adult patients with at least one filled prescription of ALK-inhibitors identified by the national prescription register. Only prescriptions filled at pharmacies can be captured in prescription registers, as they do not include data on hospital drugs. ALK-inhibitor treatments for patients with NSCLC are given primarily outside of the hospital setting minimizing the selection bias under the inclusion criteria.

Exclusion Criteria:

-not applicable

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Innovations AB Sollentuna Sweden 19190

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04647110
Other Study ID Numbers:
  • B7461035
  • SEQUIA
First Posted:
Nov 30, 2020
Last Update Posted:
Jul 13, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Study population included participants aged greater than or equal to 18 years at index date (date of first ALK TKI prescription), with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who had at least one filled prescription of ALK tyrosine kinase inhibitors (TKI) registered in the Swedish Prescribed Drug Register, between 01-Jan-2012 to 31-Dec-2020. Data of eligible participants were assessed in approximately 3 months of this retrospective observational study.
Pre-assignment Detail According to application sent to ethical counsel for this study, it was pre-planned not to report data for those cohorts/groups which had less than (<) 5 participants at the index date. Hence, due to ethical compliance study team ensured results would only be displayed on an aggregate level for reporting arms having greater than or equal to (>=) 5 participants at index date.
Arm/Group Title Participants With No First Line Chemotherapy Participants With First Line Chemotherapy
Arm/Group Description Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, with no first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib. Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, along with first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib.
Period Title: Overall Study
STARTED 345 204
COMPLETED 345 204
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Participants With No First Line Chemotherapy Participants With First Line Chemotherapy Total
Arm/Group Description Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, with no first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib. Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, along with first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib. Total of all reporting groups
Overall Participants 345 204 549
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
63.08
(13.96)
63.24
(13.28)
63.13
(13.70)
Sex: Female, Male (Count of Participants)
Female
189
54.8%
112
54.9%
301
54.8%
Male
156
45.2%
92
45.1%
248
45.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%

Outcome Measures

1. Secondary Outcome
Title Duration of Treatment: Based on Treatment Cohort Groups
Description Duration of treatment was defined as number of days on treatment calculated based on pharmaceutical specialties in Sweden (FASS) recommended dose for filled prescriptions of ALK-inhibitors taking permissible gap and stockpiling into account. Results were reported for treatment cohort groups based on generation of ALK treatment and were as following: Group A1 = chemotherapy + crizotinib (first generation ALK TKI) + any second (2nd) generation ALK TKI; Group A2 = crizotinib + any 2nd generation ALK TKI; Group B1: chemotherapy + crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group B2 = crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group C1 = chemotherapy + crizotinib + any 2nd generation ALK TKI + lorlatinib (third generation ALK TKI); Group C2: crizotinib + any 2nd generation ALK TKI + lorlatinib and Group D1 = any 2nd generation ALK TKI + any other 2nd generation ALK TKI.
Time Frame From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure based on generation of ALK treatment.
Arm/Group Title Group A1 Group A2 Group B1 Group B2 Group C1 Group C2 Group D1
Arm/Group Description Participants included in this arm received chemotherapy, crizotinib, and any second generation ALK TKI, in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received crizotinib and any second generation ALK TKI in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received chemotherapy, crizotinib and any two second generation ALK TKIs in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received, crizotinib and any two second generation ALK TKIs in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received chemotherapy, crizotinib, any second generation ALK TKI and lorlatinib in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received crizotinib, any second generation ALK TKI and lorlatinib in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received any two second generation ALK TKIs in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib.
Measure Participants 29 71 10 14 5 9 9
Mean (Standard Deviation) [Years]
1.66
(1.28)
1.86
(1.31)
3.37
(1.24)
2.45
(1.53)
2.56
(1.42)
2.72
(1.03)
1.36
(0.75)
2. Secondary Outcome
Title Duration of Treatment: Based on Chemotherapy Status
Description Duration of treatment was defined as number of days on treatment calculated based on pharmaceutical specialties in Sweden (FASS) recommended dose for filled prescriptions of ALK-inhibitors taking permissible gap and stockpiling into account. Results were reported based on chemotherapy status.
Time Frame From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed.
Arm/Group Title Participants With No First Line Chemotherapy Participants With First Line Chemotherapy
Arm/Group Description Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, with no first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib. Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, along with first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib.
Measure Participants 345 204
Mean (Standard Deviation) [Years]
1.23
(1.28)
1.07
(1.28)
3. Secondary Outcome
Title Duration of Treatment: Based on ALK Sequencing, 1 Line of ALK TKI Treatment
Description Duration of treatment was defined as number of days on treatment calculated based on FASS recommended dose for filled prescriptions of ALK-inhibitors taking permissible gap and stockpiling into account. Reporting arms were based on type of ALK TKI, with or without chemotherapy. ALK TKIs considered were crizotinib, alectinib, ceritinib.
Time Frame From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed (N)" signifies participants evaluable for this measure and received only 1 line of ALK TKIs with/ without chemotherapy. Due to ethical compliance, it was pre-planned not to report data for those reporting groups which had <5 participants at the index date.
Arm/Group Title Crizotinib Alectinib Ceritinib Crizotinib + Chemotherapy Alectinib + Chemotherapy Ceritinib + Chemotherapy
Arm/Group Description Participants included in this arm received only crizotinib in real world practices Participants included in this arm received only alectinib in real world practices. Participants included in this arm received only ceritinib in real world practices. Participants included in this arm received crizotinib in real world practices along with chemotherapy. Participants included in this arm received alectinib in real world practices along with chemotherapy. Participants included in this arm received ceritinib in real world practices along with chemotherapy.
Measure Participants 116 105 4 95 41 5
First Line ALK TKI Treatment Duration
0.72
(1.19)
0.92
(0.82)
NA
(NA)
0.50
(0.80)
0.80
(0.88)
1.01
(1.23)
Total Sequence Treatment Duration
0.72
(1.19)
0.92
(0.82)
NA
(NA)
0.50
(0.80)
0.80
(0.88)
1.01
(1.23)
4. Secondary Outcome
Title Duration of Treatment: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment
Description Duration of treatment was defined as number of days on treatment calculated based on FASS recommended dose for filled prescriptions of ALK-inhibitors taking permissible gap and stockpiling into account. Reporting arms were based on type of first line ALK TKI treatment, and second line of ALK TKI treatment, with or without chemotherapy.
Time Frame From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. "Overall Number of Participants Analyzed (N)": participants evaluable for this measure and received only 2 lines of ALK TKIs with/ without chemotherapy. Groups with "N" =0: no participants with respective ALK TKI sequencing. Due to ethical compliance, it was pre-planned not to report data for those reporting groups which had <5 participants at the index date.
Arm/Group Title Crizotinib + Alectinib Crizotinib + Brigatinib Crizotinib + Ceritinib Alectinib + Brigatinib Alectinib + Ceritinib Alectinib + Lorlatinib Ceritinib + Alectinib Ceritinib + Brigatinib Ceritinib + Lorlatinib Crizotinib + Alectinib + Chemotherapy Crizotinib + Brigatinib + Chemotherapy Crizotinib + Ceritinib + Chemotherapy Alectinib + Brigatinib + Chemotherapy Alectinib + Ceritinib + Chemotherapy Alectinib + Lorlatinib + Chemotherapy Ceritinib + Alectinib + Chemotherapy Ceritinib + Brigatinib + Chemotherapy Ceritinib + Lorlatinib + Chemotherapy
Arm/Group Description Participants included in this arm received crizotinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices along with chemotherapy.
Measure Participants 33 0 38 8 0 6 1 0 1 9 2 18 2 1 7 2 0 0
First Line ALK TKI Treatment Duration
1.01
(0.80)
0.62
(0.45)
0.61
(0.51)
0.95
(0.62)
NA
(NA)
NA
(NA)
1.42
(1.31)
NA
(NA)
0.81
(0.70)
NA
(NA)
NA
(NA)
0.50
(0.60)
NA
(NA)
Second Line ALK TKI Treatment Duration
1.62
(1.07)
0.58
(0.72)
0.55
(0.34)
0.27
(0.23)
NA
(NA)
NA
(NA)
0.75
(0.89)
NA
(NA)
0.37
(0.67)
NA
(NA)
NA
(NA)
0.40
(0.37)
NA
(NA)
Total Sequence Treatment Duration
2.62
(1.33)
1.21
(0.86)
1.16
(0.51)
1.22
(0.57)
NA
(NA)
NA
(NA)
2.17
(1.32)
NA
(NA)
1.18
(0.99)
NA
(NA)
NA
(NA)
0.89
(0.64)
NA
(NA)
5. Secondary Outcome
Title Duration of Treatment: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment
Description Duration of treatment was defined as number of days on treatment calculated based on FASS recommended dose for filled prescriptions of ALK-inhibitors taking permissible gap and stockpiling into account. Reporting arms were based on type of first line ALK TKI treatment, second line of ALK TKI treatment, and third line of ALK TKI treatment with or without chemotherapy.
Time Frame From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. "Overall Number of Participants Analyzed (N)": participants evaluable for this measure and received only 3 lines of ALK TKIs with/ without chemotherapy. Groups with "N" =0: no participants with respective ALK TKI sequencing. Due to ethical compliance, it was pre-planned not to report data for those reporting groups which had <5 participants at the index date.
Arm/Group Title Crizotinib + Alectinib + Ceritinib Crizotinib + Alectinib + Lorlatinib Crizotinib + Alectinib + Brigatinib Crizotinib + Ceritinib + Alectinib Crizotinib + Ceritinib + Lorlatinib Crizotinib + Ceritinib + Brigatinib Crizotinib + Brigatinib + Alectinib Crizotinib + Brigatinib + Lorlatinib Alectinib + Brigatinib + Lorlatinib Alectinib + Lorlatinib + Brigatinib Alectinib + Lorlatinib + Ceritinib Ceritinib + Alectinib + Lorlatinib Ceritinib + Alectinib + Brigatinib Crizotinib + Alectinib + Ceritinib + Chemotherapy Crizotinib + Alectinib + Lorlatinib + Chemotherapy Crizotinib + Alectinib + Brigatinib + Chemotherapy Crizotinib + Ceritinib + Alectinib + Chemotherapy Crizotinib + Ceritinib + Lorlatinib + Chemotherapy Crizotinib + Ceritinib + Brigatinib + Chemotherapy Crizotinib + Brigatinib + Alectinib + Chemotherapy Crizotinib + Brigatinib + Lorlatinib + Chemotherapy Alectinib + Brigatinib + Lorlatinib + Chemotherapy Alectinib + Lorlatinib + Brigatinib + Chemotherapy Alectinib + Lorlatinib + Ceritinib + Chemotherapy Ceritinib + Alectinib + Lorlatinib + Chemotherapy Ceritinib + Alectinib + Brigatinib + Chemotherapy
Arm/Group Description Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and ceritinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment and alectinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment and alectinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment and ceritinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, ceritinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment, alectinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment, alectinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment, ceritinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy.
Measure Participants 0 7 3 11 1 0 0 1 1 1 0 0 0 1 1 3 6 2 0 0 2 0 0 0 0 0
First Line ALK TKI Treatment Duration
1.12
(1.13)
NA
(NA)
0.70
(0.38)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
1.12
(0.63)
NA
(NA)
NA
(NA)
Second Line ALK TKI Treatment Duration
1.29
(0.69)
NA
(NA)
0.85
(0.81)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
1.53
(1.31)
NA
(NA)
NA
(NA)
Third Line ALK TKI Treatment Duration
0.47
(0.37)
NA
(NA)
0.85
(0.90)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
0.68
(1.07)
NA
(NA)
NA
(NA)
Total Sequence Treatment Duration
2.88
(1.13)
NA
(NA)
2.39
(1.65)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
3.34
(1.01)
NA
(NA)
NA
(NA)
6. Secondary Outcome
Title Duration of Treatment: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment
Description Duration of treatment was defined as number of days on treatment calculated based on FASS recommended dose for filled prescriptions of ALK-inhibitors taking permissible gap and stockpiling into account. In this outcome measure, duration of treatment was reported for participants who received >=4 lines of ALK inhibitor treatment, with or without chemotherapy.
Time Frame From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and received >= 4 lines of ALK TKI treatment with or without chemotherapy.
Arm/Group Title >=4 Lines of ALK TKI >=4 Lines of ALK TKI With Chemotherapy
Arm/Group Description Participants included in this arm received at least 4 different ALK TKIs, in real world practices. Participants included in this arm received at least 4 different ALK TKIs, in real world practices along with chemotherapy.
Measure Participants 8 7
First Line ALK TKI Treatment Duration
1.09
(0.61)
1.56
(0.82)
Second Line ALK TKI Treatment Duration
1.01
(0.73)
0.73
(0.49)
Third Line ALK TKI Treatment Duration
0.80
(0.63)
0.63
(0.56)
Fourth Line ALK TKI Treatment Duration
0.52
(0.48)
0.47
(0.50)
Total Sequence Treatment Duration
3.42
(0.98)
3.40
(1.76)
7. Primary Outcome
Title Overall Survival (OS): Based on Treatment Cohort Groups
Description OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. Results were reported for treatment cohort groups based on generation of ALK treatment and were as following: Group A1 = chemotherapy + crizotinib (first generation ALK TKI) + any second (2nd) generation ALK TKI; Group A2 = crizotinib + any 2nd generation ALK TKI; Group B1: chemotherapy + crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group B2 = crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group C1 = chemotherapy + crizotinib + any 2nd generation ALK TKI + lorlatinib (third generation ALK TKI); Group C2: crizotinib + any 2nd generation ALK TKI + lorlatinib and Group D1 = any 2nd generation ALK TKI + any other 2nd generation ALK TKI.
Time Frame From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure based on generation of ALK treatment.
Arm/Group Title Group A1 Group A2 Group B1 Group B2 Group C1 Group C2 Group D1
Arm/Group Description Participants included in this arm received chemotherapy, crizotinib, and any second generation ALK TKI, in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received crizotinib and any second generation ALK TKI in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received chemotherapy, crizotinib and any two second generation ALK TKIs in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received, crizotinib and any two second generation ALK TKIs in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received chemotherapy, crizotinib, any second generation ALK TKI and lorlatinib in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received crizotinib, any second generation ALK TKI and lorlatinib in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received any two second generation ALK TKIs in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib.
Measure Participants 29 71 10 14 5 9 9
Median (95% Confidence Interval) [Years]
1.94
2.30
4.56
2.94
NA
5.41
NA
8. Primary Outcome
Title Overall Survival: Based on Chemotherapy Status
Description OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. Results were reported based on chemotherapy status.
Time Frame From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed.
Arm/Group Title Participants With No First Line Chemotherapy Participants With First Line Chemotherapy
Arm/Group Description Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, with no first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib. Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, along with first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib.
Measure Participants 345 204
Median (95% Confidence Interval) [Years]
2.02
1.44
9. Primary Outcome
Title Overall Survival: Based on Central Nervous System (CNS) Metastases Status
Description OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure, participants were grouped on basis of their CNS-metastases status.
Time Frame From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed.
Arm/Group Title Participants With No CNS Metastases Participants With CNS Metastases
Arm/Group Description Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, with or without first line chemotherapy treatment and had no CNS metastases during 2 years period prior to index date. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, with or without first line chemotherapy treatment and had CNS metastases during 2 years period prior to index date. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib.
Measure Participants 520 29
Median (95% Confidence Interval) [Years]
1.94
0.61
10. Primary Outcome
Title Overall Survival: Based on ALK Sequencing, 1 Line of ALK TKI Treatment
Description OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure, OS was reported for participants who received 1 line of ALK TKI treatment. Reporting arms were based on type of ALK TKI, with or without chemotherapy. ALK TKIs considered were crizotinib, alectinib, ceritinib.
Time Frame From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed (N)" signifies participants evaluable for this measure and received only 1 line of ALK TKIs with/ without chemotherapy. Due to ethical compliance, it was pre-planned not to report data for those reporting groups which had <5 participants at the index date.
Arm/Group Title Crizotinib Alectinib Ceritinib Crizotinib + Chemotherapy Alectinib + Chemotherapy Ceritinib + Chemotherapy
Arm/Group Description Participants included in this arm received only crizotinib in real world practices. Participants included in this arm received only alectinib in real world practices. Participants included in this arm received only ceritinib in real world practices. Participants included in this arm received crizotinib in real world practices along with chemotherapy. Participants included in this arm received alectinib in real world practices along with chemotherapy. Participants included in this arm received ceritinib in real world practices along with chemotherapy.
Measure Participants 116 105 4 95 41 5
Median (95% Confidence Interval) [Years]
0.88
NA
NA
0.63
NA
0.59
11. Primary Outcome
Title Overall Survival: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment
Description OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure OS was reported for participants who received 2 lines of ALK TKI treatment. Reporting arms were based on type of first line ALK TKI treatment and second line of ALK TKI treatment, with or without chemotherapy.
Time Frame From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. "Overall Number of Participants Analyzed (N)": participants evaluable for this measure and received only 2 lines of ALK TKIs with/ without chemotherapy. Groups with "N" =0: no participants with respective ALK TKI sequencing. Due to ethical compliance, it was pre-planned not to report data for those reporting groups which had <5 participants at the index date.
Arm/Group Title Crizotinib + Alectinib Crizotinib + Brigatinib Crizotinib + Ceritinib Alectinib + Brigatinib Alectinib + Ceritinib Alectinib + Lorlatinib Ceritinib + Alectinib Ceritinib + Brigatinib Ceritinib + Lorlatinib Crizotinib + Alectinib + Chemotherapy Crizotinib + Brigatinib + Chemotherapy Crizotinib + Ceritinib + Chemotherapy Alectinib + Brigatinib + Chemotherapy Alectinib + Ceritinib + Chemotherapy Alectinib + Lorlatinib + Chemotherapy Ceritinib + Alectinib + Chemotherapy Ceritinib + Brigatinib + Chemotherapy Ceritinib + Lorlatinib + Chemotherapy
Arm/Group Description Participants included in this arm received crizotinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices along with chemotherapy.
Measure Participants 33 0 38 8 0 6 1 0 1 9 2 18 2 1 7 2 0 0
Median (95% Confidence Interval) [Years]
NA
1.27
NA
NA
NA
NA
2.69
NA
1.38
NA
NA
NA
NA
12. Primary Outcome
Title Overall Survival: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment
Description OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure OS was reported for participants who received 3 lines of ALK inhibitor treatment. Reporting arms were based on type of first line ALK TKI treatment, second line of ALK TKI treatment and third line of ALK TKI treatment with or without, chemotherapy.
Time Frame From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. "Overall Number of Participants Analyzed (N)": participants evaluable for this measure and received only 3 lines of ALK TKIs with/ without chemotherapy. Groups with "N" =0: no participants with respective ALK TKI sequencing. Due to ethical compliance, it was pre-planned not to report data for those reporting groups which had <5 participants at the index date.
Arm/Group Title Crizotinib + Alectinib + Ceritinib Crizotinib + Alectinib + Lorlatinib Crizotinib + Alectinib + Brigatinib Crizotinib + Ceritinib + Alectinib Crizotinib + Ceritinib + Lorlatinib Crizotinib + Ceritinib + Brigatinib Crizotinib + Brigatinib + Alectinib Crizotinib + Brigatinib + Lorlatinib Alectinib + Brigatinib + Lorlatinib Alectinib + Lorlatinib + Brigatinib Alectinib + Lorlatinib + Ceritinib Ceritinib + Alectinib + Lorlatinib Ceritinib + Alectinib + Brigatinib Crizotinib + Alectinib + Ceritinib + Chemotherapy Crizotinib + Alectinib + Lorlatinib + Chemotherapy Crizotinib + Alectinib + Brigatinib + Chemotherapy Crizotinib + Ceritinib + Alectinib + Chemotherapy Crizotinib + Ceritinib + Lorlatinib + Chemotherapy Crizotinib + Ceritinib + Brigatinib + Chemotherapy Crizotinib + Brigatinib + Alectinib + Chemotherapy Crizotinib + Brigatinib + Lorlatinib + Chemotherapy Alectinib + Brigatinib + Lorlatinib + Chemotherapy Alectinib + Lorlatinib + Brigatinib +Chemotherapy Alectinib + Lorlatinib + Ceritinib + Chemotherapy Ceritinib + Alectinib + Lorlatinib + Chemotherapy Ceritinib + Alectinib + Brigatinib + Chemotherapy
Arm/Group Description Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and ceritinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment and alectinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment and alectinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment and ceritinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, ceritinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment, alectinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment, alectinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment, ceritinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy.
Measure Participants 0 7 3 11 1 0 0 1 1 1 0 0 0 1 1 3 6 2 0 0 2 0 0 0 0 0
Median (95% Confidence Interval) [Years]
5.41
NA
2.78
NA
NA
NA
NA
NA
NA
NA
4.06
NA
NA
13. Primary Outcome
Title Overall Survival: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment
Description OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure, OS was reported for participants who received >=4 lines of ALK inhibitor treatment with or without chemotherapy.
Time Frame From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and received >= 4 lines of ALK TKI treatment with or without chemotherapy.
Arm/Group Title >=4 Lines of ALK TKI >=4 Lines of ALK TKI With Chemotherapy
Arm/Group Description Participants included in this arm received at least 4 different ALK TKIs, in real world practices. Participants included in this arm received at least 4 different ALK TKIs, in real world practices along with chemotherapy.
Measure Participants 8 7
Median (95% Confidence Interval) [Years]
5.49
5.27
14. Primary Outcome
Title Percentage of Participants Alive After 5 Years From Index Date: Based on Treatment Cohort Groups
Description Results were reported for treatment cohort groups based on generation of ALK treatment and were as following: Group A1 = chemotherapy + crizotinib (first generation ALK TKI) + any second (2nd) generation ALK TKI; Group A2 = crizotinib + any 2nd generation ALK TKI; Group B1: chemotherapy + crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group B2 = crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group C1 = chemotherapy + crizotinib + any 2nd generation ALK TKI + lorlatinib (third generation ALK TKI); Group C2: crizotinib + any 2nd generation ALK TKI + lorlatinib and Group D1 = any 2nd generation ALK TKI + any other 2nd generation ALK TKI.
Time Frame 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed (N)" signifies participants who evaluable for this measure with a follow up of 5 years post index date. Reporting groups with "N" =0 signifies that no participant had a follow up of 5 years post index date.
Arm/Group Title Group A1 Group A2 Group B1 Group B2 Group C1 Group C2 Group D1
Arm/Group Description Participants included in this arm received chemotherapy, crizotinib, and any second generation ALK TKI, in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received crizotinib and any second generation ALK TKI in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received chemotherapy, crizotinib and any two second generation ALK TKIs in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received, crizotinib and any two second generation ALK TKIs in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received chemotherapy, crizotinib, any second generation ALK TKI and lorlatinib in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received crizotinib, any second generation ALK TKI and lorlatinib in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received any two second generation ALK TKIs in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib.
Measure Participants 16 21 5 2 3 1 0
Number [Percentage of participants]
6.25
1.8%
9.52
4.7%
40.00
7.3%
50.00
NaN
66.67
NaN
100
NaN
15. Primary Outcome
Title Percentage of Participants Alive After 5 Years From Index Date: Based on Chemotherapy Status
Description Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on chemotherapy status.
Time Frame 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure with a follow up of 5 years post index date.
Arm/Group Title Participants With No First Line Chemotherapy Participants With First Line Chemotherapy
Arm/Group Description Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, with no first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib. Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, along with first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib.
Measure Participants 61 61
Number [Percentage of participants]
16.39
4.8%
16.39
8%
16. Primary Outcome
Title Percentage of Participants Alive After 5 Years From Index Date: Based on CNS Metastases Status
Description Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on CNS metastases status.
Time Frame 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure with a follow up of 5 years post index date.
Arm/Group Title Participants With No CNS Metastases Participants With CNS Metastases
Arm/Group Description Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, with or without first line chemotherapy treatment and had no CNS metastases during 2 years period prior to index date. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib. Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, with or without first line chemotherapy treatment and had CNS metastases during 2 years period prior to index date. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib.
Measure Participants 116 6
Number [Percentage of participants]
17.24
5%
0.00
0%
17. Primary Outcome
Title Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 1 Line of ALK TKI Treatment
Description Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 1 line of ALK TKI treatment, were reported. Reporting arms were based on type of first line ALK TKI treatment, with or without chemotherapy. ALK TKIs considered were crizotinib, alectinib, ceritinib.
Time Frame 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure with a follow up of 5 years post index date. Reporting arm with "Overall Number of Participants Analyzed" = 0, signifies that no participant had a follow up of 5 years post index date.
Arm/Group Title Crizotinib Alectinib Ceritinib Crizotinib + Chemotherapy Alectinib + Chemotherapy Ceritinib + Chemotherapy
Arm/Group Description Participants included in this arm received only crizotinib in real world practices. Participants included in this arm received only alectinib in real world practices. Participants included in this arm received only ceritinib in real world practices. Participants included in this arm received crizotinib in real world practices along with chemotherapy. Participants included in this arm received alectinib in real world practices along with chemotherapy. Participants included in this arm received ceritinib in real world practices along with chemotherapy.
Measure Participants 35 0 0 32 0 0
Number [Percentage of participants]
11.43
3.3%
0.00
0%
18. Primary Outcome
Title Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment
Description Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 2 lines of ALK TKI treatment, were reported. Reporting arms were based on type of first line ALK TKI treatment and second line of ALK TKI treatment, with or without chemotherapy.
Time Frame 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed (N)" signifies participants who evaluable for this measure with a follow up of 5 years post index date. Reporting groups with "N" =0 signifies that no participant had a follow up of 5 years post index date.
Arm/Group Title Crizotinib + Alectinib Crizotinib + Brigatinib Crizotinib + Ceritinib Alectinib + Brigatinib Alectinib + Ceritinib Alectinib + Lorlatinib Ceritinib + Alectinib Ceritinib + Brigatinib Ceritinib + Lorlatinib Crizotinib + Alectinib + Chemotherapy Crizotinib + Brigatinib + Chemotherapy Crizotinib + Ceritinib + Chemotherapy Alectinib + Brigatinib + Chemotherapy Alectinib + Ceritinib + Chemotherapy Alectinib + Lorlatinib + Chemotherapy Ceritinib + Alectinib + Chemotherapy Ceritinib + Brigatinib + Chemotherapy Ceritinib + Lorlatinib + Chemotherapy
Arm/Group Description Participants included in this arm received crizotinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices along with chemotherapy.
Measure Participants 3 0 18 0 0 0 0 0 0 2 0 14 0 0 0 0 0 0
Number [Percentage of participants]
66.67
19.3%
0.00
0%
0.00
0%
7.14
NaN
19. Primary Outcome
Title Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment
Description Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 3 lines of ALK TKI treatment. Reporting arms were based on type of first line ALK TKI treatment, second line of ALK TKI treatment, and third line of ALK TKI treatment, with or without chemotherapy.
Time Frame 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed (N)" signifies participants who evaluable for this measure with a follow up of 5 years post index date. Reporting groups with "N" =0 signifies that no participant had a follow up of 5 years post index date.
Arm/Group Title Crizotinib + Alectinib + Ceritinib Crizotinib + Alectinib + Lorlatinib Crizotinib + Alectinib + Brigatinib Crizotinib + Ceritinib + Alectinib Crizotinib + Ceritinib + Lorlatinib Crizotinib + Ceritinib + Brigatinib Crizotinib + Brigatinib + Alectinib Crizotinib + Brigatinib + Lorlatinib Alectinib + Brigatinib + Lorlatinib Alectinib + Lorlatinib + Brigatinib Alectinib + Lorlatinib + Ceritinib Ceritinib + Alectinib + Lorlatinib Ceritinib + Alectinib + Brigatinib Crizotinib + Alectinib + Ceritinib + Chemotherapy Crizotinib + Alectinib + Lorlatinib + Chemotherapy Crizotinib + Alectinib + Brigatinib + Chemotherapy Crizotinib + Ceritinib + Alectinib + Chemotherapy Crizotinib + Ceritinib + Lorlatinib + Chemotherapy Crizotinib + Ceritinib + Brigatinib + Chemotherapy Crizotinib + Brigatinib + Alectinib + Chemotherapy Crizotinib + Brigatinib + Lorlatinib + Chemotherapy Alectinib + Brigatinib + Lorlatinib +Chemotherapy Alectinib + Lorlatinib + Brigatinib +Chemotherapy Alectinib + Lorlatinib + Ceritinib + Chemotherapy Ceritinib + Alectinib + Lorlatinib + Chemotherapy Ceritinib + Alectinib + Brigatinib + Chemotherapy
Arm/Group Description Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and ceritinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment and alectinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment and alectinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment and ceritinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, ceritinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment, alectinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment, alectinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment, ceritinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy.
Measure Participants 0 1 0 2 0 0 0 0 0 0 0 0 0 0 0 0 4 0 0 0 0 0 0 0 0 0
Number [Percentage of participants]
100.00
29%
50.00
24.5%
25.00
4.6%
20. Primary Outcome
Title Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment
Description Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, data is reported for participants who received >=4 lines of ALK inhibitor treatment with or without chemotherapy.
Time Frame 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure with a follow up of 5 years post index date.
Arm/Group Title >=4 Lines of ALK TKI >=4 Lines of ALK TKI With Chemotherapy
Arm/Group Description Participants included in this arm received at least 4 different ALK TKIs, in real world practices. Participants included in this arm received at least 4 different ALK TKIs, in real world practices along with chemotherapy.
Measure Participants 2 5
Number [Percentage of participants]
100.00
29%
100.00
49%
21. Primary Outcome
Title Percentage of Participants Alive After 6 Years From Index Date: Based on Treatment Cohort Groups
Description Results were reported for treatment cohort groups based on generation of ALK treatment and were as following: Group A1 = chemotherapy + crizotinib (first generation ALK TKI) + any second (2nd) generation ALK TKI; Group A2 = crizotinib + any 2nd generation ALK TKI; Group B1: chemotherapy + crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group B2 = crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group C1 = chemotherapy + crizotinib + any 2nd generation ALK TKI + lorlatinib (third generation ALK TKI); Group C2: crizotinib + any 2nd generation ALK TKI + lorlatinib and Group D1 = any 2nd generation ALK TKI + any other 2nd generation ALK TKI.
Time Frame 6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed (N)" signifies participants who evaluable for this measure with a follow up of 6 years post index date. Reporting groups with "N" =0 signifies that no participant had a follow up of 6 years post index date.
Arm/Group Title Group A1 Group A2 Group B1 Group B2 Group C1 Group C2 Group D1
Arm/Group Description Participants included in this arm received chemotherapy, crizotinib, and any second generation ALK TKI, in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received crizotinib and any second generation ALK TKI in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received chemotherapy, crizotinib and any two second generation ALK TKIs in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received, crizotinib and any two second generation ALK TKIs in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received chemotherapy, crizotinib, any second generation ALK TKI and lorlatinib in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received crizotinib, any second generation ALK TKI and lorlatinib in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib. Participants included in this arm received any two second generation ALK TKIs in real world practices. Second generation ALK TKIs considered were alectinib, brigatinib, or ceritinib.
Measure Participants 5 3 1 0 1 0 0
Number [Percentage of participants]
0.00
0%
0.00
0%
0.00
0%
0.00
NaN
22. Primary Outcome
Title Percentage of Participants Alive After 6 Years From Index Date: Based on Chemotherapy Status
Description Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on chemotherapy status.
Time Frame 6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure with a follow up of 6 years post index date.
Arm/Group Title Participants With No First Line Chemotherapy Participants With First Line Chemotherapy
Arm/Group Description Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, with no first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib. Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, along with first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib.
Measure Participants 20 26
Number [Percentage of participants]
10.00
2.9%
3.85
1.9%
23. Primary Outcome
Title Percentage of Participants Alive After 6 Years From Index Date: Based on CNS Metastases Status
Description Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on CNS metastases status.
Time Frame 6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure with a follow up of 6 years post index date.
Arm/Group Title Participants With No CNS Metastases Participants With CNS Metastases
Arm/Group Description Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, with or without first line chemotherapy treatment and had no CNS metastases during 2 years period prior to index date. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, with or without first line chemotherapy treatment and had CNS metastases during 2 years period prior to index date. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib.
Measure Participants 44 2
Number [Percentage of participants]
6.82
2%
0.00
0%
24. Primary Outcome
Title Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 1 Line of ALK TKI Treatment
Description Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 1 line of ALK TKI treatment, were reported. Reporting arms were based on type of first line ALK TKI treatment, with or without chemotherapy. ALK TKIs considered were crizotinib, alectinib, ceritinib.
Time Frame 6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure with a follow up of 6 years post index date. Reporting arm with "Overall Number of Participants Analyzed" = 0, signifies that no participant had a follow up of 6 years post index date.
Arm/Group Title Crizotinib Alectinib Ceritinib Crizotinib + Chemotherapy Alectinib + Chemotherapy Ceritinib + Chemotherapy
Arm/Group Description Participants included in this arm received only crizotinib in real world practices. Participants included in this arm received only alectinib in real world practices. Participants included in this arm received only ceritinib in real world practices. Participants included in this arm received crizotinib in real world practices along with chemotherapy. Participants included in this arm received alectinib in real world practices along with chemotherapy. Participants included in this arm received ceritinib in real world practices along with chemotherapy.
Measure Participants 16 0 0 16 0 0
Number [Percentage of participants]
12.50
3.6%
0.00
0%
25. Primary Outcome
Title Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment
Description Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 2 lines of ALK TKI treatment, were reported. Reporting arms were based on type of first line ALK TKI treatment and second line of ALK TKI treatment, with or without chemotherapy.
Time Frame 6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed (N)" signifies participants who evaluable for this measure with a follow up of 6 years post index date. Reporting groups with "N" =0 signifies that no participant had a follow up of 6 years post index date.
Arm/Group Title Crizotinib + Alectinib Crizotinib + Brigatinib Crizotinib + Ceritinib Alectinib + Brigatinib Alectinib + Ceritinib Alectinib + Lorlatinib Ceritinib + Alectinib Ceritinib + Brigatinib Ceritinib + Lorlatinib Crizotinib + Alectinib + Chemotherapy Crizotinib + Brigatinib + Chemotherapy Crizotinib + Ceritinib + Chemotherapy Alectinib + Brigatinib + Chemotherapy Alectinib + Ceritinib + Chemotherapy Alectinib + Lorlatinib + Chemotherapy Ceritinib + Alectinib + Chemotherapy Ceritinib + Brigatinib + Chemotherapy Ceritinib + Lorlatinib + Chemotherapy
Arm/Group Description Participants included in this arm received crizotinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK KI treatment and ceritinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK KI treatment and alectinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK KI treatment and brigatinib as second line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK KI treatment and lorlatinib as second line ALK TKI treatment, in real world practices along with chemotherapy.
Measure Participants 1 0 2 0 0 0 0 0 0 0 0 5 0 0 0 0 0 0
Number [Percentage of participants]
0.00
0%
0.00
0%
0.00
0%
26. Primary Outcome
Title Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment
Description Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure OS was reported for participants who received 3 lines of ALK inhibitor treatment. Reporting arms were based on type of first line ALK TKI treatment, second line of ALK TKI treatment, and third line of ALK TKI treatment, with or without chemotherapy.
Time Frame 6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed (N)" signifies participants who evaluable for this measure with a follow up of 6 years post index date. Reporting groups with "N" =0 signifies that no participant had a follow up of 6 years post index date.
Arm/Group Title Crizotinib + Alectinib + Ceritinib Crizotinib + Alectinib + Lorlatinib Crizotinib + Alectinib + Brigatinib Crizotinib + Ceritinib + Alectinib Crizotinib + Ceritinib + Lorlatinib Crizotinib + Ceritinib + Brigatinib Crizotinib + Brigatinib + Alectinib Crizotinib + Brigatinib + Lorlatinib Alectinib + Brigatinib + Lorlatinib Alectinib + Lorlatinib + Brigatinib Alectinib + Lorlatinib + Ceritinib Ceritinib + Alectinib + Lorlatinib Ceritinib + Alectinib + Brigatinib Crizotinib + Alectinib + Ceritinib + Chemotherapy Crizotinib + Alectinib + Lorlatinib + Chemotherapy Crizotinib + Alectinib + Brigatinib + Chemotherapy Crizotinib + Ceritinib + Alectinib + Chemotherapy Crizotinib + Ceritinib + Lorlatinib + Chemotherapy Crizotinib + Ceritinib + Brigatinib + Chemotherapy Crizotinib + Brigatinib + Alectinib + Chemotherapy Crizotinib + Brigatinib + Lorlatinib + Chemotherapy Alectinib + Brigatinib + Lorlatinib + Chemotherapy Alectinib + Lorlatinib + Brigatinib + Chemotherapy Alectinib + Lorlatinib + Ceritinib + Chemotherapy Ceritinib + Alectinib + Lorlatinib + Chemotherapy Ceritinib + Alectinib + Brigatinib + Chemotherapy
Arm/Group Description Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and ceritinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment and alectinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment and alectinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment and ceritinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and lorlatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment and brigatinib as third line ALK TKI treatment, in real world practices. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, ceritinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment, alectinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, ceritinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment, alectinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received crizotinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK TKI treatment, brigatinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received alectinib as first line ALK TKI treatment, lorlatinib as second line ALK TKI treatment, ceritinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, lorlatinib as third line ALK TKI treatment, in real world practices along with chemotherapy. Participants included in this arm received ceritinib as first line ALK TKI treatment, alectinib as second line ALK TKI treatment, brigatinib as third line ALK TKI treatment, in real world practices along with chemotherapy.
Measure Participants 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0
Number [Percentage of participants]
0.00
0%
27. Primary Outcome
Title Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment
Description Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, data is reported for participants who received >=4 lines of ALK inhibitor treatment with or without chemotherapy.
Time Frame 6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)

Outcome Measure Data

Analysis Population Description
Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure with a follow up of 6 years post index date.
Arm/Group Title >=4 Lines of ALK TKI >=4 Lines of ALK TKI With Chemotherapy
Arm/Group Description Participants included in this arm received at least 4 different ALK TKIs, in real world practices. Participants included in this arm received at least 4 different ALK TKIs, in real world practices along with chemotherapy.
Measure Participants 1 3
Number [Percentage of participants]
0.00
0%
33.33
16.3%

Adverse Events

Time Frame Not applicable as adverse events not collected during the study
Adverse Event Reporting Description Due to non-interventional nature of study, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not be met; hence, adverse events were not collected and reported.
Arm/Group Title Participants With No First Line Chemotherapy Participants With First Line Chemotherapy
Arm/Group Description Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, with no first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib. Participants included in this arm received at least one filled prescription of ALK TKIs in real world practices, along with first line chemotherapy treatment. ALK TKIs were crizotinib, alectinib, brigatinib, ceritinib, or lorlatinib.
All Cause Mortality
Participants With No First Line Chemotherapy Participants With First Line Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Serious Adverse Events
Participants With No First Line Chemotherapy Participants With First Line Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Participants With No First Line Chemotherapy Participants With First Line Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)

Limitations/Caveats

Due to ethical compliance study team ensured results would not be reported for those cohorts/groups which had less than 5 participants at the index date.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title Pfizer ClinicalTrials.gov Call Center
Organization Pfizer Inc.
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04647110
Other Study ID Numbers:
  • B7461035
  • SEQUIA
First Posted:
Nov 30, 2020
Last Update Posted:
Jul 13, 2022
Last Verified:
Mar 1, 2022