For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  2. 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
  3. No prior systemic treatment for metastatic NSCLC
  4. High tumor tissue PD-L1 expression
  5. Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  6. Adequate hematologic and end-organ function
  7. For participants enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry.

EXCLUSION CRITERIA

  1. Known mutation in the EGFR gene or an ALK fusion oncogene
  2. Symptomatic, untreated, or actively progressing central nervous system 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. 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
  6. Severe infection within 4 weeks prior to initiation of study treatment
  7. Positive test result for human immunodeficiency virus (HIV)
  8. Active hepatitis B or hepatitis C
  9. Treatment with investigational therapy within 28 days prior to initiation of study treatment
  10. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  11. Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to initiation of study treatment.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 888-662-6728 (U.S. Only)Email iconEmail Study Center

Study’s details


Contition

Non-Small Cell Lung Cancer

Age

18+

Phase

Phase 3

Participants needed

660

Est. Completion Date

Feb 2025

Treatment type

Interventional


Sponsor

Hoffmann-La Roche

ClinicalTrials.gov identifier

NCT04294810

Study number

GO41717

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