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

NCT ID: NCT02813785

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 565 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2022-12-27

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

MDPL3280A, RO5541267; Taxotere

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Cancer Hospital Chinese Academy of Medical Sciences.

Beijing, , China

Beijing Cancer Hospital

Beijing, , China

Beijing Chest Hospital; Oncology Department

Beijing, , China

Affiliated Hospital of Bengbu Medical College

Bengbu, , China

the First Hospital of Jilin University

Changchun, , China

Jilin Cancer Hospital

Changchun, , China

Changzhou First People's Hospital

Changzhou, , China

West China Hospital, Sichuan University

Chengdu, , China

Second Affiliated Hospital of Third Military Medical University

Chongqing, , China

Third Affiliated Hospital of Third Military Medical University

Chongqing, , China

Guangdong General Hospital

Guangzhou, , China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, , China

Sun Yet-sen University Cancer Center

Guangzhou, , China

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, , China

Sir Run Run Shaw Hospital

Hangzhou, , China

Harbin Medical University Cancer Hospital

Harbin, , China

Jiangsu Cancer Hospital

Nanjing, , China

The Affiliated Hospital of Medical College Qingdao University

Qingdao, , China

Shanghai chest hospital

Shanghai, , China

Zhongshan Hospital Fudan University

Shanghai, , China

Fudan University Shanghai Cancer Center

Shanghai, , China

Liaoning cancer Hospital & Institute

Shenyang, , China

Tianjin Medical University General Hospital

Tianjin, , China

The First Affiliated Hospital of Xian Jiao Tong University

Xi'an, , China

Zhejiang Cancer Hospital

Zhejiang, , China

Henan Cancer Hospital

Zhengzhou, , China

Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

Sarawak, Sarawak, Malaysia

Hospital Sultan Ismail; Oncology

Johor Bahru, , Malaysia

Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi

Kuala Lumpur, , Malaysia

National Cancer Centre; Medical Oncology

Singapore, , Singapore

Kyungpook National University Medical Center

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Chulalongkorn Hospital; Medical Oncology

Bangkok, , Thailand

Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

Bangkok, , Thailand

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

Bangkok, , Thailand

CHIANG MAI UNI HOSPITAL; FACULTY OF MEDICINE; Medical Oncology unit

Chiang Mai, , Thailand

Countries

China; Malaysia; Singapore; South Korea; Thailand

Other Identifiers

YO29232

Identifier Type: -

Identifier Source: org_study_id