Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments atezolizumab, carboplatin, cisplatin, gemcitabine
Phase phase 3
Target PD-1
Sponsor Hoffmann-La Roche
Start date May 2015
End date September 2017
Trial size 8 participants
Trial identifier NCT02409355, 2014-003106-33, GO29432

Summary

This randomized, open-label study is designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in participants with chemotherapy-naive, Stage IV squamous NSCLC.

United States New York
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
atezolizumab MPDL3280A; Tecentriq
Atezolizumab will be administered at a dose of 1200 milligrams (mg) by IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit.
(Active Comparator)
Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
carboplatin
Carboplatin will be administered at area under the concentration-time curve (AUC) 5 IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
cisplatin
Cisplatin will be administered at 75 milligrams per square meter (mg/m^2) IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
gemcitabine
Gemcitabine will be administered at 1000 mg/m^2 (when coadministered with carboplatin) or 1250 mg/m^2 (when coadministered with cisplatin) IV infusion on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles.

Primary Outcomes

Measure
Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
time frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)

Secondary Outcomes

Measure
Percentage of Participants With Adverse Events
time frame: From baseline up to approximately 2.5 years
Percentage of Participants With an Objective Response (Complete Response [CR] Plus Partial Response [PR]) as Assessed by the Investigator Using RECIST v1.1
time frame: Baseline up to death or disease progression, whichever occurs first (Up to approximately 2.5 years)
Overall Survival (OS)
time frame: Baseline up to death (Up to approximately 2.5 years)
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score
time frame: Baseline up to approximately 2.5 years
PFS as Determined by an Independent Review Facility (IRF) Using RECIST v1.1
time frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1
time frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)
Time in Response (TIR) as Determined by the Investigator Using RECIST v1.1
time frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)
Percentage of Participants Who are Alive at Year 1 and 2
time frame: Year 1 and 2
TTD in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30) Questionnaire Score
time frame: Baseline up to approximately 2.5 years
TTD in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality of Life-Core Lung Cancer Module 13 (QLQ-C13) Questionnaire Score
time frame: Baseline up to approximately 2.5 years
Change From Baseline in Patient-Reported Lung Cancer Symptoms on the Symptom Severity Score of the SILC Scale
time frame: Baseline up to approximately 2.5 years
Pharmacokinetics: Minimum Observed Serum Concentration (Cmin) of Atezolizumab
time frame: Predose on Day 1 of Cycles (Cy) 2, 3, 4, 8, 16, and every 8 cycles thereafter (cycle length=21 days), at treatment discontinuation, and at 120 days after the last dose of atezolizumab (up to approximately 2.5 years)
Pharmacokinetics: Maximum Observed Serum Concentration (Cmax) of Atezolizumab
time frame: Predose on Day 1 of Cy2,3,4,8,16, and every 8 cycles thereafter (cycle length=21 days), 0.5 hour post-infusion on Day 1 of Cycle 1, at treatment discontinuation, and at 120 days after the last dose of atezolizumab (up to approximately 2.5 years)
Percentage of Participants With Anti-Therapeutic Antibody (ATA) to Atezolizumab
time frame: Predose on Day 1 of Cy2,3,4,8,16, and every 8 cycles thereafter (cycle length=21 days), at treatment discontinuation, and at 120 days after the last dose of atezolizumab (up to approximately 2.5 years)

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed Stage IV squamous NSCLC - Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening - No prior treatment for Stage IV squamous NSCLC - Measurable disease as defined by RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Adequate hematologic and end-organ function Exclusion Criteria: - Active or untreated central nervous system (CNS) metastases - Untreated or inadequately treated spinal cord compression - Leptomeningeal disease - Uncontrolled pleural effusion, pericardial effusion, or ascites - Uncontrolled tumor-related pain - Uncontrolled hypercalcemia - Any other malignancies within 5 years except those with negligible risk of metastasis or death - Pregnant or lactating women - Known hypersensitivity to any component of atezolizumab formulation or other study medication - History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes - Prior allogeneic bone marrow or solid organ transplantation - Positive human immunodeficiency virus (HIV) test - Active hepatitis B or C - Active tuberculosis - Significant cardiovascular disease - Severe infection or major surgery within 4 weeks prior to randomization - Use of any approved anti-cancer therapy within 3 weeks prior to treatment - Use of an investigational agent or participation in another clinical trial within 4 weeks prior to randomization - Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization - Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies - Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization

Additional Information

Official title A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With Gemcitabine+Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.