Skip to main content
OpenTrials
Completed

NCT Number: NCT02813785

A Study of Atezolizumab Compared With Docetaxel in Non-Small Cell Lung Cancer (NSCLC) After Failure With Platinum-Containing Chemotherapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Prior treatment with or hypersensitivity to study drug(s) or related compounds
  • Inability to discontinue strong cytochrome P450 (CYP) 3A4 inhibitors
  • Prior allogeneic bone marrow or solid organ transplant
  • Known PD-L1-negative expression status
  • Positive human immunodeficiency virus (HIV) or active hepatitis B or C
  • Receipt of a live attenuated vaccine within 4 weeks prior to randomization
  • Treatment with systemic immunomodulators within 4 weeks or five half-lives (whichever is shorter) prior to randomization
  • Treatment with systemic corticosteroids within 2 weeks prior to randomization

Treatment and study plan

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

Drug

Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.

Other names: MDPL3280A, RO5541267

docetaxel

Drug

Docetaxel will be administered as 75 milligrams per square meter (mg/m^2) via IV infusion on Day 1 of each 21-day cycle.

Other names: Taxotere

Primary outcomes

  1. Overall Survival (OS)

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

Secondary outcomes

  1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

    Time frame: Baseline until disease progression or death from any cause (up to approximately 3 years)

  2. Percentage of Participants with Objective Response According to RECIST v1.1

    Time frame: Baseline until disease progression or death from any cause (up to approximately 3 years)

  3. Duration of Objective Response According to RECIST v1.1

    Time frame: From first objective response until disease progression or death from any cause (up to approximately 3 years)

  4. Percentage of Participants with Adverse Events

    Time frame: From start of treatment until 90 days after treatment discontinuation or initiation of other anti-cancer therapy (up to approximately 3 years)

  5. Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

    Time frame: 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)

  6. Minimum Observed Serum Concentration (Cmin) of Atezolizumab

    Time frame: 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)

  7. 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)

    Time frame: From start of treatment until treatment discontinuation (up to approximately 3 years)

  8. TTD in Lung Cancer Symptoms According to EORTC QLQ Lung Cancer Module (LC13)

    Time frame: From start of treatment until treatment discontinuation (up to approximately 3 years)

  9. Health-Related Quality of Life According to EORTC QLQ-C30 Score

    Time frame: Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)

  10. Health-Related Quality of Life According to EORTC QLQ-LC13 Score

    Time frame: Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: IMpower210

Important dates

Study start
2016
Primary completion
2019
Study completion
2022
First posted
Jun 27, 2016
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.