A Study of Atezolizumab Compared With Docetaxel in Non-Small Cell Lung Cancer (NSCLC) After Failure With Platinum-Containing Chemotherapy (IMpower210)

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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 565
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences.
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Beijing, China, 101149
    • Beijing Chest Hospital; Oncology Department
  • Bengbu, China, 233004
    • Affiliated Hospital of Bengbu Medical College
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changchun, China, 132013
    • Jilin cancer hospital
  • Changzhou, China, 213003
    • Changzhou First People's Hospital
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • ChongQing, China, 400042
    • Third Affiliated Hospital of Third Military Medical University
  • Chongqing, China, 400030
    • Second Affiliated Hospital of Third Military Medical University
  • Guangzhou, China, 510080
    • Guangdong General Hospital
  • Guangzhou, China, 510120
    • The First Affiliated Hospital of Guangzhou Medical University
  • Guangzhou City, China, 510663
    • Sun Yet-sen University Cancer Center
  • Hangzhou, China, 310003
    • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • Hangzhou City, China, 310018
    • Sir Run Run Shaw Hospital
  • Harbin, China, 150081
    • Harbin medical university cancer hospital
  • Nanjing City, China, 211100
    • Jiangsu Cancer Hospital
  • Qingdao, China, 266003
    • The Affiliated Hospital of Medical College Qingdao University
  • Shanghai, China, 200030
    • Shanghai Chest Hospital
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University
  • Shanghai City, China, 200120
    • Fudan University Shanghai Cancer Center
  • Shenyang, China, 110042
    • Liaoning cancer Hospital & Institute
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Xi'an City, China, 710061
    • The First Affiliated Hospital of Xian Jiao Tong University
  • Zhejiang, China, 310022
    • Zhejiang Cancer Hospital
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Medical Center
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Jeollanam-do, Korea, Republic of, 58128
    • Chonnam National University Hwasun Hospital
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
• Malaysia
  • Johor Bahru, Malaysia, 81100
    • Hospital Sultan Ismail; Oncology
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
  • Sarawak, Malaysia, 93586
    • Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
• Singapore
  • Singapore, Singapore, 169610
    • National Cancer Centre; Medical Oncology
• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital; Medical Oncology
  • Bangkok, Thailand, 10700
    • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
  • Chiang Mai, Thailand, 50200
    • CHIANG MAI UNI HOSPITAL; FACULTY OF MEDICINE; Medical Oncology unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; 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
Active Comparator: 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.	Drug: Docetaxel; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	Baseline until death from any cause (up to approximately 3 years)

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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 Adverse Events	From start of treatment until 90 days after treatment discontinuation or initiation of other anti-cancer therapy (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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimate): June 27, 2016

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Antibodies; Atezolizumab
• Other Study ID Numbers: YO29232