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

NCT05735327 | Active Not Recruiting

• 1 other identifier: Brigatinib-4004
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 12

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).

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Real-World Progression Free Survival (rwPFS)

  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.

  Up to 33 months

Secondary Outcomes (3)

• Overall Survival (OS)

  Up to 33 months

• Real-World Overall Response Rate (rwORR)

  Up to 33 months

• Time to Discontinuation (TTD)

  Up to 33 months

Study Arms (1)

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

Interventions

No intervention DRUG

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

Brigatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with ALK positive NSCLC who received brigatinib in first-line treatment in Poland.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (12)

Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii

Wroclaw, Dolnoslskie, 53-413, Poland

Location

Szpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu.

Poznan, Greater Poland Voivodeship, 60-355, Poland

Location

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, Greater Poland Voivodeship, 60-569, Poland

Location

Centrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie- Panstwowy Instytut Badawczy Oddzial w Krakowie

Krakow, Lesser Poland Voivodeship, 31-115, Poland

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie

Krakow, Lesser Poland Voivodeship, 31-202, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

Lublin, Lublin Voivodeship, 20-954, Poland

Location

Instytut Gruzlicy i Chorob Pluc

Warsaw, Masovian Voivodeship, 01-138, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Podkarpackie Centrum Chorob Pluc

Rzeszów, Podkarpackie Voivodeship, 35-241, Poland

Location

Centrum Pulmonologii i Torakochirurgii w Bystrej

Bystra, Slskie, 43-360, Poland

Location

SPZOZ Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Lodzi Centralny Szpital Weteranow

Lodz, Łódź Voivodeship, 90-549, Poland

Location

Related Links

• Click here for more information about this trial in easy-to-understand language.
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Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen collected would be blood samples.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: May 22, 2023
• Primary Completion (Estimated): April 26, 2027
• Study Completion (Estimated): April 26, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

PL (12)