Overview

This trial is active, not recruiting.

Condition non-squamous non-small cell lung cancer
Treatments atezolizumab [tecentriq], docetaxel
Phase phase 3
Target PD-1
Sponsor Hoffmann-La Roche
Start date March 2014
End date December 2017
Trial size 1225 participants
Trial identifier NCT02008227, 2013-003331-30, GO28915

Summary

This global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Patients will be randomized 1:1 to receive either docetaxel (75 mg/m2 intravenous infusion) or Atezolizumab (1200 mg intravenous infusion) every three weeks. Treatment may continue as long as patients are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
atezolizumab [tecentriq]
1200 mg intravenous infusion on Day 1 of each 21-day cycle
(Active Comparator)
docetaxel
75 mg/m2 intravenous infusion on Day 1 of each 21-day cycle

Primary Outcomes

Measure
Overall survival (OS)
time frame: Approximately 4.5 years

Secondary Outcomes

Measure
Incidence of adverse events
time frame: Up to 1 year
Overall response rate determined using Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1)
time frame: Up to 1 year
Progression-free survival (PFS) evaluated with RECIST v. 1.1
time frame: Up to 1 year
Duration of response evaluated with RECIST v. 1.1 for responding patients
time frame: Up to 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 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 or combined modality (e.g., chemoradiation) regimen with curative intent - 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 - 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

Additional Information

Official title A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB COMPARED WITH DOCETAXEL IN PATIENTS WITH NON−SMALL CELL LUNG CANCER AFTER FAILURE WITH PLATINUM CONTAINING CHEMOTHERAPY [OAK]
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.