A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT03563716

Run by

Genentech, Inc.

People needed

135

Starts

2018-08-10

Expected to finish

2025-11-14

Last updated by the study team

2026-05-04

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Oncology Associates, PC - HAL — Tempe, Arizona, United States
• SCRI Florida Cancer Specialists South — Fort Myers, Florida, United States
• Florida Cancer Specialists - NORTH - SCRI - PPDS — St. Petersburg, Florida, United States
• Illinois Cancer Specialists — Arlington Heights, Illinois, United States
• Illinois Cancer Care — Peoria, Illinois, United States
• University of Kansas Medical Center — Westwood, Kansas, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Research Medical Center — Kansas City, Missouri, United States
• SCRI Tennessee Oncology — Nashville, Tennessee, United States
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
• Northwest Cancer Specialists - Vancouver — Vancouver, Washington, United States
• ICO Paul Papin — Angers, France
• Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest — Bordeaux, France
• Centre Georges François Leclerc — Dijon, France
• Hopital Nord AP-HM — Marseille, France
• Institut De Cancerologie De L'Ouest — Saint-Herblain, France
• Institute of Lung Diseases Vojvodina — Kamenitz, Južnobanatski Okrug, Serbia
• Clinical Center of Serbia — Belgrade, Serbia
• Clinical Hospital Center Bezanijska Kosa — Belgrade, Serbia
• Chungbuk National University Hospital — Cheongju-si, South Korea
• Seoul National University Bundang Hospital — Gyeonggi-do, South Korea
• Seoul National University Hospital — Seoul, South Korea
• Kangbuk Samsung Hospital — Seoul, South Korea
• Severance Hospital, Yonsei University Health System — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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