A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy

Hoffmann-La Roche38 sites in 5 countries565 target enrollmentJuly 1, 2016

ConditionsCarcinoma, Non-Small-Cell Lung

InterventionsAtezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Docetaxel

DrugsAtezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Docetaxel

Overview

Phase: Phase 3
Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Hoffmann-La Roche
Enrollment: 565
Locations: 38
Primary Endpoint: Overall Survival (OS)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This Phase III, multicenter, open-label, randomized, controlled study is designed to evaluate the efficacy and safety of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab compared with docetaxel in participants with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen. Treatment may continue until disease progression, loss of clinical benefit, or unacceptable toxicity.

Registry

clinicaltrials.gov

Start Date

July 1, 2016

End Date

December 27, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically documented, locally advanced or metastatic NSCLC
•Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens available or at least 12 unstained, freshly cut serial sections with associated pathology report that are evaluable for PD-L1 expression and epidermal growth factor receptor (EGFR) mutation status prior to enrollment, except for known sensitizing EGFR mutations in which case 10 unstained slides are required and there is no need for central testing of EGFR mutation status
•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 and/or neoadjuvant regimen or combined modality with curative intent
•Measurable disease per RECIST v1.1
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Life expectancy greater than or equal to (\>/=) 12 weeks
•Adequate hematologic and end organ function
•Agreement to remain abstinent or use contraceptive methods among women of childbearing potential or male partners of women of childbearing potential
•Recovery from all acute toxicities from previous therapy

Exclusion Criteria

•Active or untreated central nervous system (CNS) metastases
•Spinal cord compression not definitively treated or not clinically stable
•Leptomeningeal disease
•Uncontrolled pleural or pericardial effusions or ascites requiring recurrent drainage
•Uncontrolled tumor-related pain
•Uncontrolled hypercalcemia
•Malignancies other than NSCLC within 5 years prior to randomization, except for those curatively treated with negligible risk of metastasis or death
•Pregnant or lactating women
•Significant cardiovascular, pulmonary, or autoimmune disease
•Severe infection or major surgery within 4 weeks, or antibiotic treatment within 2 weeks prior to randomization

Arms & Interventions

Atezolizumab

Participants will receive atezolizumab until loss of clinical benefit and will thereafter enter survival follow-up until death, loss to follow-up, withdrawal, or study end.

Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Docetaxel

Participants will receive docetaxel until disease progression per standard RECIST v1.1 criteria or unacceptable toxicity and will thereafter enter survival follow-up until death, loss to follow-up, withdrawal, or study end.

Intervention: Docetaxel

Outcomes

Primary Outcomes

Overall Survival (OS)

Time Frame: Baseline until death from any cause (up to approximately 3 years)

Secondary Outcomes

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1(Baseline until disease progression or death from any cause (up to approximately 3 years))
Percentage of Participants with Adverse Events(From start of treatment until 90 days after treatment discontinuation or initiation of other anti-cancer therapy (up to approximately 3 years))
Health-Related Quality of Life According to EORTC QLQ-C30 Score(Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years))
Percentage of Participants with Objective Response According to RECIST v1.1(Baseline until disease progression or death from any cause (up to approximately 3 years))
Duration of Objective Response According to RECIST v1.1(From first objective response until disease progression or death from any cause (up to approximately 3 years))
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Atezolizumab(Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall))
Health-Related Quality of Life According to EORTC QLQ-LC13 Score(Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years))
Minimum Observed Serum Concentration (Cmin) of Atezolizumab(Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall))
Time to Deterioration (TTD) in Lung Cancer Symptoms According to European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 C30)(From start of treatment until treatment discontinuation (up to approximately 3 years))
TTD in Lung Cancer Symptoms According to EORTC QLQ Lung Cancer Module (LC13)(From start of treatment until treatment discontinuation (up to approximately 3 years))