Summary

for people ages 18 years and up (full criteria)
at UCLA UC Davis
study started
estimated completion:

Description

Summary

This global, multicenter, open-label, randomized, controlled study will evaluate 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 will be randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue 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.

Official Title

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

Keywords

Non-Squamous Non-Small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung Docetaxel Atezolizumab Antibodies, Monoclonal Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Univ of Calif, Los Angeles; Hematology/Oncology
    Los Angeles California 90095 United States
  • UC Davis; Comprehensive Cancer Center
    Sacramento California 95817 United States
  • Scripps Clinic; Hematology & Oncology
    La Jolla California 92037-1027 United States
  • Kaiser Permanente - San Francisco (2238 Geary)
    San Francisco California 94115 United States
  • K. Permanente - S. San Fran
    South San Francisco California 94080 United States
  • Roy & Patricia Disney Family Cancer Center
    Burbank California 91505 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02008227
Phase
Phase 3
Study Type
Interventional
Last Updated