Brigatinib treatment for adults with Non-Small Cell Lung Cancer

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

This study is testing how well brigatinib works as a first treatment for adults with ALK positive Non-Small Cell Lung Cancer by seeing how long it keeps their cancer from getting worse.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Takeda (industry)
• Drugs / interventions: brigatinib
• Locations: 12 sites (Wroclaw, Dolnoslskie and 11 other locations)
• Trial ID: NCT05735327 on ClinicalTrials.gov

What this trial studies

This observational study focuses on adults with ALK positive Non-Small Cell Lung Cancer (NSCLC) receiving brigatinib as their first-line treatment. The primary goal is to assess the duration of time participants experience no disease progression after starting brigatinib. Participants will be monitored during regular clinical visits over a period of up to 33 months, with data collected on their response to the treatment. The study will involve approximately 50 participants across multiple centers in Poland.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with ALK positive NSCLC who are starting brigatinib as their first-line therapy.

Not a fit: Patients currently participating in an interventional clinical trial for ALK positive NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and duration of brigatinib treatment for patients with NSCLC.

How similar studies have performed: While this approach is observational, similar studies evaluating treatment responses in NSCLC have shown promising results.

Eligibility criteria

Inclusion Criteria

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

Exclusion Criteria

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

Where this trial is running

Wroclaw, Dolnoslskie and 11 other locations

• Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii — Wroclaw, Dolnoslskie, Poland (RECRUITING)
• Centrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy — Bydgoszcz, Kujawsko-Pomorskie, Poland (RECRUITING)
• SPZOZ Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Lodzi Centralny Szpital Weteranow — Lodz, Lodzkie, Poland (RECRUITING)
• Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie — Lublin, Lubelskie, Poland (RECRUITING)
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie- Panstwowy Instytut Badawczy Oddzial w Krakowie — Krakow, Malopolskie, Poland (NOT_YET_RECRUITING)
• Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie — Krakow, Malopolskie, Poland (RECRUITING)
• Instytut Gruzlicy i Chorob Pluc — Warszawa, Mazowieckie, Poland (RECRUITING)
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy — Warszawa, Mazowieckie, Poland (RECRUITING)
• Podkarpackie Centrum Chorob Pluc — Rzeszow, Podkarpackie, Poland (NOT_YET_RECRUITING)
• Centrum Pulmonologii i Torakochirurgii w Bystrej — Bystra, Slskie, Poland (NOT_YET_RECRUITING)
• Szpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu. — Poznan, Wielkopolskie, Poland (RECRUITING)
• Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu — Poznan, Wielkopolskie, Poland (RECRUITING)

Study contacts

• Study coordinator: Takeda Contact

Conditions: Non-small Cell Lung Cancer, Drug Therapy