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
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.
Checked against the public recordLast updated Dec 20, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Hoffmann-La Roche
- Interventions being studied
- Drug: Atezolizumab; Drug: Docetaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Comprehensive Blood/Cancer CtrBakersfield, California
- Roy & Patricia Disney Family Cancer CenterBurbank, California
- St. Jude Heritage Healthcare; Virgiia K.Crosson Can CtrFullerton, California
- Kaiser Permanente - HaywardHayward, California
- Scripps Clinic; Hematology & OncologyLa Jolla, California
- Pacific Shores Medical GroupLong Beach, California
- Univ of Calif, Los Angeles; Hematology/OncologyLos Angeles, California
- North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can CtrNorthridge, California
- Kaiser Permanente - OaklandOakland, California
- TMPN/ Cancer Care AssociatesRedondo Beach, California
- Kaiser Permanente - RosevilleRoseville, California
- Kaiser Permanente Sacramento Medical CenterSacramento, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 20, 2019. Always confirm current availability with the study team.