A Study of Tiragolumab in Combination with Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Patients with Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

Phase 1

Recruiting

• Conditions: on-squamous non-small cell lung cancer (NSCLC); MedDRA version: 20.0Level: LLTClassification code: 10079440Term: Non-squamous non-small cell lung cancer Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502031-20-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-09
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, 2. Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy, 3. No prior systemic treatment for metastatic non-squamous NSCLC, 4. Known tumor PD-L1 status, 5. Measurable disease, as defined by RECIST v1.1, 6.Negative HIV test and Serology test negative for active hepatitis B virus and active hepatitis C virus at screening

Exclusion Criteria

1. Patients with NSCLC which harbors a mutation in the EGFR gene or an ALK fusion oncogene, 2. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases, 3. Active or history of autoimmune disease or immune deficiency, 4. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, 5. History of malignancy other than NSCLC within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death, 6. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4 (CTLA4), anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified