A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer
The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.
Checked against the public recordLast updated Jan 30, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Hoffmann-La Roche
- Interventions being studied
- Drug: Atezolizumab; Drug: Tiragolumab; Drug: Matching Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC * No prior systemic treatment for metastatic NSCLC * High tumor tissue PD-L1 expression * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) * Adequate hematologic and end-organ function * For participants enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry. Exclusion Criteria: * Known mutation in the EGFR gene or an ALK fusion oncogene * Symptomatic, untreated, or actively progressing central nervous system metastases * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis * Malignancies other than NSCLC within 5 years, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome * Severe infection within 4 weeks prior to initiation of study treatment * Positive test result for human immunodeficiency virus (HIV) * Active hepatitis B or hepatitis C * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies * Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to initiation of study treatment.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Rocky Mountain Cancer Center - DenverDenver, Colorado
- Yale Cancer CenterNew Haven, Connecticut
- SCRI Florida Cancer Specialists NorthSt. Petersburg, Florida
- SCRI Florida Cancer Specialists PANTallahassee, Florida
- US oncology research at Minnesota OncologySaint Paul, Minnesota
- SCRI Oncology PartnersNashville, Tennessee
- Virginia Cancer Specialists (Fairfax) - USORFairfax, Virginia
- Onc & Hem Assoc SW VirginiaSalem, Virginia
- Northwest Cancer Specialists - VancouverVancouver, Washington
- Princess Alexandra HospitalWoolloongabba, Queensland
- Austin Hospital Olivia Newton John Cancer CentreHeidelberg, Victoria
- Peter Maccallum Cancer CentreMelbourne, Victoria
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 30, 2026. Always confirm current availability with the study team.