Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment atezolizumab
Phase phase 2
Target PD-1
Sponsor Hoffmann-La Roche
Start date January 2014
End date May 2015
Trial size 667 participants
Trial identifier NCT02031458, 2013-003330-32, GO28754

Summary

This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer. Patients will receive Atezolizumab 1200 mg intravenously every 3 weeks 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

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
atezolizumab
1200 mg IV every 3 weeks

Primary Outcomes

Measure
Objective response rate (ORR), Independent review facility (IRF)-assessed according to RECIST v1.1
time frame: approximately 1 year
ORR, Investigator-assessed according to modified RECIST
time frame: approximately 1 year

Secondary Outcomes

Measure
Duration of response
time frame: approximately 3 years
Progression-free survival
time frame: approximately 3 years
Overall survival
time frame: approximately 6 years
Safety: Incidence of adverse events
time frame: approximately 6 years
Pharmacokinetics: Maximum serum concentration (Cmax)
time frame: up to 72 hours post-dose Cycle 1
Pharmacokinetics: Minimum serum concentration under steady-state conditions within a dosing interval
time frame: pre-dose Day 1 of Cycles 2, 3, 4 and 8 and within 30 days of last dose.

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 - PD-L1-positive tumor status as determined by an immunohistochemistry (IHC) assay based on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory - Measurable disease, as defined by RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: - Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed: Hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (TKIs) approved for treatment of NSCLC discontinued > 7 days prior to Cycle 1, Day 1 - Central nervous system (CNS) disease, including treated brain metastases. - Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome - History of autoimmune disease - History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted. - Active hepatitis B or hepatitis C - HIV positive - 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, MULTICENTER, SINGLE-ARM STUDY OF ATEZOLIZUMAB IN PATIENTS WITH PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.
Location data was received from the National Cancer Institute and was last updated in June 2016.