Study on Tiragolumab and Atezolizumab Combination vs. Placebo and Atezolizumab for Untreated Advanced Non-Small Cell Lung Cancer

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04294810

This clinical trial is testing whether adding the drug tiragolumab to atezolizumab is more effective than using atezolizumab alone in patients with advanced non-small cell lung cancer (NSCLC) that cannot be removed by surgery or has spread to other parts of the body.

Patient Parameters

Program Overview

The study aims to compare the effectiveness and safety of a new drug combination, tiragolumab plus atezolizumab, against a placebo plus atezolizumab in patients with advanced non-small cell lung cancer (NSCLC) that has not been treated before. Participants will be randomly assigned to receive either the new drug combination or the placebo combination. The study focuses on patients whose cancer cells have a high level of a protein called PD-L1, and who do not have specific genetic mutations known as EGFR or ALK.

Eligibility Criteria

Inclusion Criteria

  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a confirmed diagnosis of locally advanced or recurrent non-small cell lung cancer (NSCLC) that cannot be removed by surgery or treated with radiation, or have Stage IV NSCLC that has spread.
  • Have not received any prior treatment for metastatic NSCLC.
  • Have high levels of PD-L1 protein in the tumor tissue.
  • Have measurable cancer according to standard criteria.
  • Have adequate blood cell counts and organ function.
  • For participants in the extended China enrollment phase: must be a current resident of mainland China or Taiwan and of Chinese ancestry.

Exclusion Criteria

  • Have known genetic mutations in the EGFR gene or ALK fusion oncogene.
  • Have untreated or worsening cancer that has spread to the brain or spinal cord.
  • Have a history of autoimmune diseases or immune system deficiencies.
  • Have a history of certain lung diseases like idiopathic pulmonary fibrosis or active lung inflammation.
  • Have had other cancers within the past 5 years, except for certain non-threatening cancers.
  • Have had a severe infection within 4 weeks before starting the study treatment.
  • Test positive for HIV.
  • Have active hepatitis B or C infections.
  • Have received any investigational therapy within 28 days before starting the study treatment.
  • Have previously been treated with certain immune therapies, including CD137 agonists or immune checkpoint inhibitors.
  • Have used systemic immune-stimulating agents within 4 weeks or 5 drug elimination half-lives before starting the study treatment.

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