CompletedPhase 2NCT01903993

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"

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.

Checked against the public recordLast updated Oct 2, 2019 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations65
SponsorHoffmann-La Roche
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Hoffmann-La Roche
Interventions being studied
Drug: Docetaxel; Drug: Atezolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Arizona Oncology Associates, PC - HOPETucson, Arizona
  • Genesis Cancer CenterHot Springs, Arkansas
  • Loma Linda University Medical CenterLoma Linda, California
  • Kaiser Permanente - San MarcosSan Marcos, California
  • Kaiser Permanente - VallejoVallejo, California
  • Innovative Clinical Research InstituteWhittier, California
  • Rocky Mountain Cancer Centers - Colorado Springs (Circle)Lone Tree, Colorado
  • Ocala Oncology CenterOcala, Florida
  • Georgia Cancer SpecialistsAtlanta, Georgia
  • Ingalls Memorial HospitalHarvey, Illinois
  • Illinois Cancer CarePeoria, Illinois
  • New England Cancer SpecialistsScarborough, Maine

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 2, 2019. Always confirm current availability with the study team.

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