A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Atezolizumab; Docetaxel
Intervention description: 1200 mg IV infusion on Day 1 of each 21-day cycle; 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle
Intervention MeSH terms: Docetaxel; Atezolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1225.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and
      safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody)compared with
      docetaxel in participants with locally advanced or metastatic non-small cell lung cancer
      (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1
      to receive either docetaxel or atezolizumab. Treatment may continue as long as participants
      experienced clinical benefit as assessed by the investigator, i.e., in the absence of
      unacceptable toxicity or symptomatic deterioration attributed to disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC

          -  Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens

          -  Disease progression during or following treatment with a prior platinum-containing
             regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease
             recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant
             regimen or combined modality (e.g., chemoradiation) regimen with curative intent

          -  Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors
             (RECIST) version 1.1

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Known active or untreated central nervous system (CNS) metastases

          -  Malignancies other than NSCLC within 5 years prior to randomization, with the
             exception of those with a negligible risk of metastasis or death and treated with
             expected curative outcome

          -  History of autoimmune disease

          -  History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced
             pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening
             chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation
             field (fibrosis) is permitted

          -  Active hepatitis B or hepatitis C

          -  Prior treatment with docetaxel

          -  Prior treatment with cluster of differentiation 137 (CD137) agonists,
             anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1
             (anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents