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)
- Conditions
- on-Small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503920-14-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 385
Whole-body positron emission tomography/computed tomography scan (PET-CT) performed prior and within 42 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), Ability to swallow entrectinib intact, without chewing, crushing, or opening the capsules (Cohort A2)
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method