A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.
Checked against the public recordLast updated May 4, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Genentech, Inc.
- Interventions being studied
- Drug: Atezolizumab; Drug: Tiragolumab; Drug: 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: * ECOG Performance Status of 0 or 1 * Histologically or cytologically documented locally advanced unresectable NSCLC, recurrent, or metastatic NSCLC of either squamous or non-squamous histology * No prior systemic treatment for locally advanced unresectable or metastatic NSCLC * Tumor PD-L1 expression * Measurable disease, as defined by RECIST v1.1 * Life expectancy \>=12 weeks * Adequate hematologic and end-organ function * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm Exclusion Criteria: Cancer-Specific Exclusions: * Patients with NSCLC known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Spinal cord compression not definitively treated with surgery and/or radiation, and/or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>=2 weeks prior to screening * History of leptomeningeal disease * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Uncontrolled tumor-related pain * Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab * Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome General Medical Exclusions: * Pregnant and lactating women * Significant cardiovascular disease * Severe infections within 4 weeks prior to randomization * Major surgical procedure other than for diagnosis within 4 weeks prior to randomization Treatment-Specific Exclusions: * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation * History of autoimmune disease * Prior allogeneic bone marrow transplantation or solid organ transplantation * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan * Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or active tuberculosis * Administration of a live, attenuated vaccine within 4 weeks prior to randomization
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Arizona Oncology Associates, PC - HALTempe, Arizona
- SCRI Florida Cancer Specialists SouthFort Myers, Florida
- Florida Cancer Specialists - NORTH - SCRI - PPDSSt. Petersburg, Florida
- Illinois Cancer SpecialistsArlington Heights, Illinois
- Illinois Cancer CarePeoria, Illinois
- University of Kansas Medical CenterWestwood, Kansas
- Karmanos Cancer InstituteDetroit, Michigan
- Research Medical CenterKansas City, Missouri
- SCRI Tennessee OncologyNashville, Tennessee
- Virginia Cancer Specialists, PCFairfax, Virginia
- Northwest Cancer Specialists - VancouverVancouver, Washington
- ICO Paul PapinAngers
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 4, 2026. Always confirm current availability with the study team.