A study of Atezolizumab for patients with non-small cell lung cancer (POPLAR)

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"

  • Cancer
  • Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Countries
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Thailand
  • Türkiye
  • United Kingdom
  • United States
Trial Identifier:

NCT01903993 2013-001142-34 GO28753

      Show trial locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT01903993, GO28753, 2013-001142-34 Trial Identifier
      Docetaxel, Atezolizumab Treatments
      Non-Small Cell Lung Cancer Condition
      Official Title

      A Phase II, Open-label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Platinum Failure

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

      Related Trials

      Use our search to find other trials on ForPatients in related disease areas.

      Non-Small Cell Lung Cancer (NSCLC)

      Clinical Research Explained

      Information about what clinical trials and observational studies are. Understand why you might want to take part in clinical research and why diversity in clinical research is important.

      Find out now