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A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer

Phase 1
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: 100000004864
Therapeutic 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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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