A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Atezolizumab; Carboplatin; Cisplatin; Gemcitabine
Intervention description: Atezolizumab will be administered at a dose of 1200 milligrams (mg) by IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit.; Carboplatin will be administered at area under the concentration-time curve (AUC) 5 IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.; Cisplatin will be administered at 75 milligrams per square meter (mg/m^2) IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.; Gemcitabine will be administered at 1000 mg/m^2 (when coadministered with carboplatin) or 1250 mg/m^2 (when coadministered with cisplatin) IV infusion on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles.
Intervention MeSH terms: Carboplatin; Gemcitabine; Atezolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, open-label study was designed to evaluate and compare the safety and
      efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected
      participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to
      low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC
      into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no
      longer applicable and formal analyses of efficacy or safety have not been performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed Stage IV squamous NSCLC

          -  Tumor programmed death-ligand 1 (PD-L1) expression, as determined by
             immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at
             screening

          -  No prior treatment for Stage IV squamous NSCLC

          -  Measurable disease as defined by RECIST v1.1

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Adequate hematologic and end-organ function

        Exclusion Criteria:

          -  Active or untreated central nervous system (CNS) metastases

          -  Untreated or inadequately treated spinal cord compression

          -  Leptomeningeal disease

          -  Uncontrolled pleural effusion, pericardial effusion, or ascites

          -  Uncontrolled tumor-related pain

          -  Uncontrolled hypercalcemia

          -  Any other malignancies within 5 years except those with negligible risk of metastasis
             or death

          -  Pregnant or lactating women

          -  Known hypersensitivity to any component of atezolizumab formulation or other study
             medication

          -  History of autoimmune disease except controlled, treated hypothyroidism or type I
             diabetes

          -  Prior allogeneic bone marrow or solid organ transplantation

          -  Positive human immunodeficiency virus (HIV) test

          -  Active hepatitis B or C

          -  Active tuberculosis

          -  Significant cardiovascular disease

          -  Severe infection or major surgery within 4 weeks prior to randomization

          -  Use of any approved anti-cancer therapy within 3 weeks prior to treatment

          -  Use of an investigational agent or participation in another clinical trial within 4
             weeks prior to randomization

          -  Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4
             weeks prior to randomization

          -  Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint
             blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic
             antibodies

          -  Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents
             within 2 weeks prior to randomization