Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments atezolizumab, docetaxel
Phase phase 2
Target PD-1
Sponsor Hoffmann-La Roche
Start date August 2013
End date May 2015
Trial size 287 participants
Trial identifier NCT01903993, 2013-001142-34, GO28753

Summary

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.

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)
Participants will receive Atezolizumab 1200 mg IV infusion every 3 weeks until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death.
atezolizumab
Participants will receive Atezolizumab 1200 mg IV infusion every 3 weeks until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death.
(Active Comparator)
Participants will receive Docetaxel 75 mg/m^2 intravenous infusion (IV) every 3 weeks until disease progression per standard RECIST criteria or unacceptable toxicity.
docetaxel
Participants will receive Docetaxel 75 mg/m^2 intravenous infusion (IV) every 3 weeks until disease progression per standard RECIST v1.1 or unacceptable toxicity.

Primary Outcomes

Measure
Overall survival
time frame: approximately 3 years

Secondary Outcomes

Measure
Duration of Response (DOR) according to RECIST criteria
time frame: Upto approximately 3 years
Overall response (partial response plus complete response) according to modified RECIST criteria
time frame: Upto approximately 3 years
Progression-free survival according to modified RECIST criteria
time frame: Upto approximately 3 years
Duration of Response (DOR) according to modified RECIST criteria
time frame: Upto approximately 3 years
Patient reported outcomes: EORTC QLQ-C30 and QLQ-LC12 questionnaires
time frame: approximately 1 year
Overall response (partial response plus complete response) according to RECIST v1.1 criteria
time frame: approximately 3 years
Progression-free survival, according to RECIST v1.1 criteria
time frame: approximately 3 years
Safety: Incidence of adverse events
time frame: Until 90 days following the last dose of MPDL3280A or receipt of another anti-cancer therapy, approximately 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A PHASE II, 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 PLATINUM FAILURE [POPLAR]
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.