A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]
Condition: Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody; Carboplatin; Nab-Paclitaxel; Paclitaxel
Intervention description: Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.; Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.; Nab-paclitaxel 100 milligrams per meter squared (mg/m^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.; Paclitaxel 200 mg/m^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m^2 IV.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Atezolizumab; Antibodies
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1021.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, open-label study will evaluate the safety and efficacy of atezolizumab
      (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel
      compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants
      with Stage IV squamous NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC

          -  Previously obtained archival tumor tissue or tissue obtained from biopsy at screening

          -  Measurable disease as defined by RECIST v1.1

          -  Adequate hematologic and end organ function

        Exclusion Criteria:

          -  Active or untreated central nervous system (CNS) metastasis

          -  Malignancies other than NSCLC within 5 years prior to randomization, with the
             exception of those with a negligible risk of metastasis or death treated with expected
             curative outcome

          -  Pregnant or lactating women

          -  History of autoimmune disease

          -  History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
             pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
             chest Computed Tomography (CT) scan, History of radiation pneumonitis in the radiation
             field (fibrosis) is permitted

          -  Positive test for Human Immunodeficiency Virus (HIV)

          -  Active hepatitis B or hepatitis C

          -  Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
             checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1
             therapeutic antibody

          -  Severe infection within 4 weeks prior to randomization

          -  Significant history of cardiovascular disease