Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced Lung Cancer

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03505515
Collaborator
(none)
6,205
1
33.1
187.2

Study Details

Study Description

Brief Summary

The purpose of the study is to document real-world pattern of care, outcomes and health resource use for participants diagnosed with and receiving treatment for advanced Non-small cell lung cancer (NSCLC) and extensive disease Small cell lung cancer (SCLC) in China.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    6205 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced/Metastatic Lung Cancer: a Retrospective Observational Study
    Actual Study Start Date :
    Dec 7, 2017
    Actual Primary Completion Date :
    Sep 11, 2020
    Actual Study Completion Date :
    Sep 11, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Lung Cancer Patricipants in China

    Participants with advanced/metastatic lung cancer (advanced NSCLC (IIIB/IV) and extensive disease SCLC) in China

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants receiving first-line systemic therapy [Approximately 36 months]

      Proportion of patients receiving first-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

    2. Proportion of participants receiving second-line systemic therapy [Approximately 36 months]

      Proportion of patients receiving second-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

    3. Proportion of participants receiving third-line systemic therapy [Approximately 36 months]

      Proportion of patients receiving third-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

    4. Proportion of participants receiving fourth-line systemic therapy [Approximately 36 months]

      Proportion of patients receiving fourth-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

    5. Distribution of first-line regimens [Approximately 36 months]

      All chemotherapy, radiation and/or biologic drugs given to a patient during the first 28 days after initiation of treatment

    6. Distribution of subsequent regimens [Approximately 36 months]

      All chemotherapy, radiation and/or biologic drugs given to a patient following first-line regimen

    7. Distribution of first-line treatment duration [Approximately 36 months]

      Calculated by the difference between the treatment start date of the first observed drug in the regimen and the last observed date of the regimen

    8. Distribution of subsequent treatment duration [Approximately 36 months]

      Calculated by the difference between the treatment start date of the first observed drug in the regimen and the last observed date of the regimen

    9. Distribution of first-line therapy completion rate [Approximately 36 months]

      Completion of more than 4 cycles

    10. Distribution of subsequent therapy completion rate [Approximately 36 months]

      Completion of more than 4 cycles

    Secondary Outcome Measures

    1. Distribution of patient demographic data [At baseline]

    2. Distribution of disease characteristic data [At baseline]

    3. Distribution of Overall Survival from first observed diagnosis to death [At baseline]

    4. Distribution of Overall Survival from the initiation of first-line systemic anti-cancer therapy to death [At baseline]

    5. Distribution of Overall Survival from the initiation of second-line systemic anti-cancer therapy to death [At baseline]

    6. Distribution of Overall Survival from the initiation of third-line systemic anti-cancer therapy to death [At baseline]

    7. Distribution of Overall Survival from the initiation of fourth-line systemic anti-cancer therapy to death [At baseline]

    8. Distribution of other cancer-directed therapies [Approximately 36 months]

      Distribution of other cancer-directed therapies including surgery and radiation as well as supportive care

    9. Distribution of Interval of Therapy [Up to 36 months]

    10. Distribution of Lung Cancer related direct health care costs [Up to 36 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologically confirmed advanced NSCLC (IIIB/IV) and extensive disease SCLC with pathology/cytology record between 1-Dec-2013 and 30-Nov-2014

    • Received inpatient treatment more than twice (inclusive) at a selected site. For hospitals with outpatient records, patients receiving oral TKI therapy and routinely (more than twice a year) followed up outpatient will be included although no inpatient records. For hospitals with outpatient chemotherapy center, patients will be include if they were prescribed with chemotherapy and routinely (more than twice a year, inclusive) followed up outpatient in the hospital

    • 18 years of age or older at initial diagnosis of IIIB/IV NSCLC and extensive disease SCLC

    Exclusion Criteria:
    • Patients who have participated in or are attending clinical trials receiving active LC therapy

    • Unknown initial diagnosis time and initial treatment time.

    • For hospitals without outpatient chemo therapy center, patients who were prescribed with chemo therapy but with no inpatient records will be excluded

    • Patients who received inpatient therapy for one time and were not routinely (more than twice a year, inclusive) followed up outpatient will be excluded

    Other protocol defined inclusion/exclusion criteria could apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Shanghai SHG China 200031

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03505515
    Other Study ID Numbers:
    • CA209-693
    First Posted:
    Apr 23, 2018
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 14, 2021