A Study of Brigatinib as Preferred First Therapy for Adults With Non-Small Cell Lung Cancer (NSCLC) ENTIRETY

Sponsor

Takeda (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05735327

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

4.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study of brigatinib in adults with Non-Small Cell Lung Cancer (NSCLC). The main aim of this study is to learn about the time period in which the condition does not worsen after the participant has received brigatinib. Another aim is to learn about the overall rate of participants who respond to the treatment with brigatinib.

Participants will receive brigatinib as part of their normal clinical practice. Data will be collected during regular visits to the hospital (a total of up to 12 visits is planned throughout study duration).

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer (NSCLC)	Drug: No intervention

Detailed Description

This is a non-interventional, prospective study of Polish participants with ALK positive NSCLC receiving Brigatinib as their first line of treatment in the scope of routine clinical practice within the frames of National Drug Program (NDP). This study will evaluate progression-free survival (from the time of the first dose of brigatinib).

This study will enrol approximately 50 participants. Participants will be enrolled in the following cohort to be observed at baseline, and every 3 months up to 33 months:

• Brigatinib

This multi-center trial will be conducted in Poland. The overall duration of the study will include approximately 18 months of enrolment and approximately 33 months of data collection and follow-up.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effectiveness and Safety of Brigatinib Treatment as First-line Therapy Administered to ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients. Prospective, Multicenter, Observational Study

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2027

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Brigatinib Participants receiving Brigatinib as part of their first-line treatment in scope of their routine clinical practice within the frames of National Drug Program (NDP) will be observed at baseline, and every 3 months (± 1 month) at routine follow-up for up to 33 months.	Drug: No intervention As this is an observational study, no intervention will be administered.

Arm

Intervention/Treatment

Brigatinib

Participants receiving Brigatinib as part of their first-line treatment in scope of their routine clinical practice within the frames of National Drug Program (NDP) will be observed at baseline, and every 3 months (± 1 month) at routine follow-up for up to 33 months.

Drug: No intervention

As this is an observational study, no intervention will be administered.

Outcome Measures

Primary Outcome Measures

Real-World Progression Free Survival (rwPFS) [Up to 33 months]
rwPFS is defined as the time from starting treatment to the time of radiographic progression according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria.

Secondary Outcome Measures

Overall Survival (OS) [Up to 33 months]
OS is defined as the time from starting treatment with brigatinib until death due to any cause or loss to follow-up.
Real-World Overall Response Rate (rwORR) [Up to 33 months]
rwORR (including intracranial response) is defined as the sum of the partial and complete response according to RECIST version 1.1. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.
Time to Discontinuation (TTD) [Up to 33 months]
TTD is defined as the time from starting treatment to the time to treatment discontinuation due to any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Adult (aged ≥18) ALK positive NSCLC participants receiving brigatinib as a first-line treatment in the scope of NDP.
Participants willing to participate in the study and signed ICF.

Exclusion Criteria

Current or planned participation in an interventional clinical trial for ALK positive non-small cell lung cancer (NSCLC).
Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy	Bydgoszcz	Poland	85-796
2	Centrum Pulmonologii i Torakochirurgii w Bystrej	Bystra	Poland	43-360
3	Uniwersyteckie Centrum Kliniczne Gdansk	Gdansk	Poland	80-952
4	Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie	Krakow	Poland	31-202
5	SPZOZ Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Lodzi Centralny Szpital Weteranow	Lodz	Poland	90-549
6	Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie	Lublin	Poland	20-954
7	Szpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu.	Poznan	Poland	60-355
8	Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu	Poznan	Poland	60-569
9	Podkarpackie Centrum Chorob Pluc	Rzeszow	Poland	35-241
10	Instytut Gruzlicy i Chorob Pluc	Warszawa	Poland	01-138
11	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy	Warszawa	Poland	02-781
12	Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii	Wroclaw	Poland	53-413

Sponsors and Collaborators

Takeda

Investigators

Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain more information on the study, click here/on this link.

Publications

None provided.

Responsible Party:

Takeda

ClinicalTrials.gov Identifier:

NCT05735327

Other Study ID Numbers:

Brigatinib-4004

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 24, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Takeda

Drug Therapy

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Feb 24, 2023