A Study of MTIG7192A in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

  • Cancer
  • Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Serbia
  • South Korea
Trial Identifier:

NCT03563716 2018-000280-81 GO40290

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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      Trial Summary

      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.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT03563716,GO40290,2018-000280-81 Trial Identifier
      Atezolizumab, Tiragolumab, Placebo Treatments
      Non-small Cell Lung Cancer Condition
      Official Title

      A Phase II, Randomized, Blinded, Placebo-Controlled Study of Tiragolumab, An Anti-TIGIT Antibody, In Combination With Atezolizumab In Chemotherapy-Naïve Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      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

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