Overview

This trial is active, not recruiting.

Condition squamous non-small cell lung cancer
Treatments atezolizumab (mpdl3280a) [tecentriq], 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, GO29432

Summary

This randomized, open-label study is designed to evaluate and compare the safety and efficacy of Atezolizumab (MPDL3280A) compared with treatment with gemcitabine + cisplatin or carboplatin in patients with chemotherapy-naive, Stage IV squamous non-small cell lung cancer (NSCLC).

United States New York
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)
Patients assigned to receive MPDL3280A single-agent chemotherapy
atezolizumab (mpdl3280a) [tecentriq]
1200 mg IV infusion every 21 days until loss of clinical benefit, unacceptable toxicity, patient or physician decision to discontinue, or death
(Active Comparator)
Patients assigned to a dual regimen of gemcitabine plus cisplatin or gemcitabine plus carboplatin
carboplatin
Area under the concentration-time curve (AUC) 5 IV infusion on Day 1 every 21 days for 4 or 6 cycles until unacceptable toxicity, patient or physician decision to discontinue, or death
cisplatin
75 mg/m^2 IV infusion on Day 1 every 21 days for 4 or 6 cycles until unacceptable toxicity, patient or physician decision to discontinue, or death
gemcitabine
1000 mg/m^2 (when coadministered with carboplatin) or 1250 mg/m2 (when coadministered with cisplatin) IV infusion on Days 1 and 8 every 21 days for 4 or 6 cycles until unacceptable toxicity, patient or physician decision to discontinue, or death

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: Up to approximately 2.5 years

Secondary Outcomes

Measure
Safety: Incidence of adverse events
time frame: Up to approximately 3.5 years
Objective response rate (ORR) as determined by the investigator using RECIST v1.1 criteria
time frame: Up to approximately 2.5 years
Overall survival (OS)
time frame: Up to approximately 3.5 years
Time to deterioration (TTD) in patient-reported lung cancer symptoms
time frame: Up to approximately 2.5 years
PFS as determined by an independent review facility (IRF) using RECIST v1.1
time frame: Up to approximately 2.5 years
Duration of response (DOR) as determined by the investigator using RECIST v1.1
time frame: Up to approximately 2.5 years
Time in response (TIR) as determined by the investigator using RECIST v1.1
time frame: Up to approximately 2.5 years
OS at 1 and 2 years
time frame: Up to approximately 3.5 years
Change from baseline in patient-reported lung cancer symptoms
time frame: Up to approximately 2.5 years
Pharmacokinetics: Minimum observed serum concentration (Cmin) of MPDL3280A
time frame: Up to approximately 2.5 years
Pharmacokinetics: Maximum observed serum concentration (Cmax) of MPDL3280A
time frame: Up to approximately 2.5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients 18 years of age or older - Histologically or cytologically confirmed Stage IV NSCLC - Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening - No prior treatment for Stage IV NSCLC - Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (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 MPDL3280A 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 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 intravenous (IV) antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, 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 MPDL3280A (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 November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.