A Study of Atezolizumab Compared With Docetaxel in Non-Small Cell Lung Cancer (NSCLC) After Failure With Platinum-Containing Chemotherapy
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT02813785
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 565
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atezolizumab Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody 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. Docetaxel 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.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Baseline until death from any cause (up to approximately 3 years)
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (38)
Cancer Hospital Chinese Academy of Medical Sciences.
π¨π³Beijing, China
Beijing Cancer Hospital
π¨π³Beijing, China
Affiliated Hospital of Bengbu Medical College
π¨π³Bengbu, China
the First Hospital of Jilin University
π¨π³Changchun, China
Second Affiliated Hospital of Third Military Medical University
π¨π³Chongqing, China
Third Affiliated Hospital of Third Military Medical University
π¨π³ChongQing, China
Sun Yet-sen University Cancer Center
π¨π³Guangzhou City, China
The First Affiliated Hospital of Guangzhou Medical University
π¨π³Guangzhou, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
π¨π³Hangzhou, China
Jiangsu Cancer Hospital
π¨π³Nanjing City, China
The Affiliated Hospital of Medical College Qingdao University
π¨π³Qingdao, China
Shanghai chest hospital
π¨π³Shanghai, China
Zhongshan Hospital Fudan University
π¨π³Shanghai, China
Liaoning cancer Hospital & Institute
π¨π³Shenyang, China
The First Affiliated Hospital of Xian Jiao Tong University
π¨π³Xi'an City, China
Zhejiang Cancer Hospital
π¨π³Zhejiang, China
Kyungpook National University Medical Center
π°π·Daegu, Korea, Republic of
Chonnam National University Hwasun Hospital
π°π·Jeollanam-do, Korea, Republic of
Chungnam National University Hospital
π°π·Daejeon, Korea, Republic of
Korea University Guro Hospital
π°π·Seoul, Korea, Republic of
Hospital Sultan Ismail; Oncology
π²πΎJohor Bahru, Malaysia
Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
π²πΎSarawak, Malaysia
Chulalongkorn Hospital; Medical Oncology
πΉπBangkok, Thailand
National Cancer Centre; Medical Oncology
πΈπ¬Singapore, Singapore
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
πΉπBangkok, Thailand
CHIANG MAI UNI HOSPITAL; FACULTY OF MEDICINE; Medical Oncology unit
πΉπChiang Mai, Thailand
Beijing Chest Hospital; Oncology Department
π¨π³Beijing, China
Jilin Cancer Hospital
π¨π³Changchun, China
Changzhou First People's Hospital
π¨π³Changzhou, China
West China Hospital, Sichuan University
π¨π³Chengdu, China
Guangdong General Hospital
π¨π³Guangzhou, China
Sir Run Run Shaw Hospital
π¨π³Hangzhou City, China
Harbin Medical University Cancer Hospital
π¨π³Harbin, China
Fudan University Shanghai Cancer Center
π¨π³Shanghai City, China
Tianjin Medical University General Hospital
π¨π³Tianjin, China
Henan Cancer Hospital
π¨π³Zhengzhou, China
Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
π²πΎKuala Lumpur, Malaysia
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
πΉπBangkok, Thailand