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

Completed · Phase 3

Conditions studied: Non-Squamous Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02008227

Run by

Hoffmann-La Roche

People needed

1225

Starts

2014-03-11

Expected to finish

2019-01-09

Last updated by the study team

2019-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• Roy & Patricia Disney Family Cancer Center — Burbank, California, United States
• St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr — Fullerton, California, United States
• Kaiser Permanente - Hayward — Hayward, California, United States
• Scripps Clinic; Hematology & Oncology — La Jolla, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• Univ of Calif, Los Angeles; Hematology/Oncology — Los Angeles, California, United States
• North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr — Northridge, California, United States
• Kaiser Permanente - Oakland — Oakland, California, United States
• TMPN/ Cancer Care Associates — Redondo Beach, California, United States
• Kaiser Permanente - Roseville — Roseville, California, United States
• Kaiser Permanente Sacramento Medical Center — Sacramento, California, United States
• UC Davis; Comprehensive Cancer Center — Sacramento, California, United States
• Kaiser Permanente - San Francisco (2238 Geary) — San Francisco, California, United States
• K. Permanente - San Jose — San Jose, California, United States
• Coastal Integrative Cancer Care — San Luis Obispo, California, United States
• Kaiser Permanente - San Marcos — San Marcos, California, United States
• K. Permanente - Santa Clara — Santa Clara, California, United States
• Central Coast Medical Oncology — Santa Maria, California, United States
• K. Permanente - S. San Fran — South San Francisco, California, United States
• Kaiser Permanente - Vallejo — Vallejo, California, United States
• K. Permanente - Walnut Creek — Walnut Creek, California, United States
• St. Mary's Hospital Regional Cancer Center — Grand Junction, Colorado, United States
• Kaiser Permanente - Franklin; Kaiser Permanente - Lone Tree — Lone Tree, Colorado, United States
• Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) — Jacksonville, Florida, United States
• Comprehensive Blood/Cancer Ctr — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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