BridgeMD
A Study to see How Well and How Safely Different Treatments Work in a Group of Patients with Non-Small Cell Lung Cancer, Chosen Based on their Biomarker Status
EU CTIS ID: 2024-511239-91-00
What this study is testing
The objective of this study was to evaluate the efficacy and/or safety of multiple therapies in patients with early-stage resectable NSCLC. Following the study’s early closure, the objectives for cohort B1 have changed. The objectives for cohort B2 remain unchanged as no participants were enrolled in that cohort or are planned to be enrolled in that cohort. Cohort B1: To explore the safety of alectinib in combination with chemotherapy in patients with completely resected Stage II, IIIA, and selected IIIB (T3N2 only; as per AJCC eighth edition), anaplastic lymphoma kinase (ALK)-positive NSCLC Cohort B2:To evaluate the efficacy of neoadjuvant treatment with alectinib in combination with chemotherapy in patients with resectable Stage II, IIIA, and selected IIIB (T3N2 only; as per AJCC, Eighth Edition), ALK-positive NSCLC
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Cohort B1: Complete resection of the primary NSCLC with negative margins
- Cohort B1: Confirmed stage II-select IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology
- Cohort B1: ECOG performance status of 0 or 1
- Cohort B2: Evaluation by the operating attending surgeon and involved medical oncologist prior to study enrollment to verify study eligibility for complete surgical resection with curative intent
- Cohort B2: Pathologically and/or histologically confirmed Stage II-IIIA and IIIB (T3N2 only) NSCLC of non-squamous (adenocarcinoma) histology
- Cohort B1 and B2: Documented ALK fusion
You likely can't join if
- Cohort B1: NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
- Cohort B1 and B2: Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Cohort B1: Prior exposure to any systemic anti-cancer therapy
- Cohort B2: Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
- Cohort B2: Known sensitivity to any component of alectinib, pemetrexed, cisplatin, or carboplatin
- Cohort B1:Prior exposure to any systemic anti-cancer therapy
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Korea, Republic of
- Chile
- China
- United Kingdom
- Brazil
- Thailand
- Mexico
- New Zealand
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Korea, Republic of; Chile; China; United Kingdom; Brazil and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.