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

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT04294810

Run by

Hoffmann-La Roche

People needed

620

Starts

2020-03-04

Expected to finish

2025-12-30

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Yale Cancer Center — New Haven, Connecticut, United States
• SCRI Florida Cancer Specialists North — St. Petersburg, Florida, United States
• SCRI Florida Cancer Specialists PAN — Tallahassee, Florida, United States
• US oncology research at Minnesota Oncology — Saint Paul, Minnesota, United States
• SCRI Oncology Partners — Nashville, Tennessee, United States
• Virginia Cancer Specialists (Fairfax) - USOR — Fairfax, Virginia, United States
• Onc & Hem Assoc SW Virginia — Salem, Virginia, United States
• Northwest Cancer Specialists - Vancouver — Vancouver, Washington, United States
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Austin Hospital Olivia Newton John Cancer Centre — Heidelberg, Victoria, Australia
• Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia
• Ordensklinikum Linz Elisabethinen — Linz, Austria
• Klinik Penzing — Vienna, Austria
• Krankenhaus Nord - Klinik Floridsdorf — Vienna, Austria
• Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda — Ijuí, Rio Grande do Sul, Brazil
• Hospital de Cancer de Barretos — Barretos, São Paulo, Brazil
• Beijing Cancer Hospital — Beijing, China
• The First Hospital of Jilin University — Changchun, China
• West China Hospital, Sichuan University — Chengdu, China
• Chongqing Cancer Hospital — Chongqing, China
• Fujian Cancer Hospital — Fuzhou, China
• Hainan General Hospital — Haikou, China
• Sir Run Run Shaw Hospital Zhejiang University — Hangzhou, China
• Harbin Medical University Cancer Hospital — Harbin, China
• Rocky Mountain Cancer Center - Denver — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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