A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Docetaxel; Atezolizumab
Intervention description: Participants received starting dose of 75 mg/m^2 every three week (q3w) until disease progression, unacceptable toxicity or death. Dose modifications were according to the locally approved label. Participants randomized to receive docetaxel had to be premedicated with corticosteroids according to local practice.; Participants received atezolizumab of 1200 mg (equivalent to an average body weight-based dose of 15 milligram per kilogram [mg/kg]) which was administered by IV infusion q3w on Day 1 of each 21 day cycle. Participants were allowed to continue treatment beyond progression per response evaluation criteria in solid tumors (RECIST) v1.1 if they were experiencing clinical benefit per investigator, did not have a decline in performance status, did not have signs or symptoms of unequivocal progression, did not have tumor progression at critical sites, and signed an informed consent signature page acknowledging deferment any standard treatment options that may exist in favor of continuing atezolizumab.
Intervention MeSH terms: Docetaxel; Atezolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 287.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, open-label, randomized study will evaluate the efficacy and safety of
      Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small
      cell lung cancer after platinum failure. Participants will be randomized to receive either
      Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per
      meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be
      continued as long as participants are experiencing 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:

          -  Adult participants, >/= 18 years of age

          -  Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell
             lung cancer (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

          -  Measurable disease, as defined by RECIST v1.1

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Known active or untreated central nervous system (CNS) metastases as determined by CT
             or MRI evaluation during screening and prior radiographic assessments

          -  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 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 CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic
             antibody or pathway-targeting agents