BridgeMD
A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)
EU CTIS ID: 2023-503920-14-00
What this study is testing
To evaluate the efficacy of study treatment (alectinib or entrectinib) compared with durvalumab in patients with biomarker-selected, locally advanced, unresectable, Stage III NSCLC who have received concurrent chemoradiotherapy (cCRT) or sequential chemoradiotherapy (sCRT) and have not had radiographic disease progression with respect to Blinded Independent Central Review (BICR)- Progression-free survival (PFS)
- Therapeutic confirmatory (Phase III)
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
- Whole-body positron emission tomography/computed tomography scan (PET-CT) performed prior and within 42 for Cohort A2 (ROS1 positive) and 50 days for Cohort A1 (ALK positive) days of the first dose of cCRT or sCRT
- Histologically or cytologically documented locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology (Version 8, American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system)
- No disease progression during or following receipt of at least 2 cycles of platinum-based cCRT or sCRT
- Documented ALK fusion positivity (Cohort A1)
- Documented ROS1 fusion positivity (Cohort A2)
- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
You likely can't join if
- Any history of previous NSCLC and/or any history of prior treatment for NSCLC
- Any evidence of Stage IV disease
- NSCLC known to have a known or likely oncogenic-driver mutation in the EGFR gene, as identified by site local testing or Sponsor central testing
- Prior treatment with ALK inhibitors (Cohort A1)
- Prior treatment with ROS1 inhibitors (Cohort A2)
- Active or history of autoimmune disease or immune deficiency
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Japan
- Thailand
- Korea, Republic of
- Brazil
- United States
- United Kingdom
- Israel
- Hong Kong
- New Zealand
- Australia
- Serbia
- Colombia
- Canada
- Chile
- India
- China
- Singapore
- Costa Rica
- Taiwan
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 Turkey; Japan; Thailand; Korea, Republic of; Brazil; United States and 14 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.