A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer
- Conditions
- Previously untreated locally advanced or metastatic non-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
- CTIS2023-505211-21-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, Histologically or cytologically documented locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC who are not eligible for curative surgery and/or definitive chemoradiotherapy, No prior systemic treatment for metastatic NSCLC, Known tumor PD-L1 status, Confirmed availability of representative tumor specimens, Adequate hematologic and end-organ function
NSCLC known to have a mutation in the EGFR gene or an ALK fusion oncogene. Known targetable c-ROS oncogene 1 (ROS1), BRAFV600E or rearranged during transfection (RET) proto-oncogene genomic aberrations, Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Untreated or clinically unstable spinal cord compression, History of leptomeningeal disease, Uncontrolled tumor-related pain. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently), 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