A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Atezolizumab; Tiragolumab; Placebo
Intervention description: Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle.; Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.; Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Intervention MeSH terms: Atezolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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