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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Baseline until death from any cause (up to approximately 3 years) |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences. | Beijing | 100021 | China | |||
| Beijing Cancer Hospital |
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| 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. |
|
|
| 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) |
| Beijing |
| 100142 |
| China |
| Beijing Chest Hospital; Oncology Department | Beijing | 101149 | China |
| Affiliated Hospital of Bengbu Medical College | Bengbu | 233004 | China |
| the First Hospital of Jilin University | Changchun | 130021 | China |
| Jilin Cancer Hospital | Changchun | 132013 | China |
| Changzhou First People's Hospital | Changzhou | 213003 | China |
| West China Hospital, Sichuan University | Chengdu | 610041 | China |
| Second Affiliated Hospital of Third Military Medical University | Chongqing | 400030 | China |
| Third Affiliated Hospital of Third Military Medical University | Chongqing | 400042 | China |
| Guangdong General Hospital | Guangzhou | 510080 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | 510120 | China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510663 | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | 310003 | China |
| Sir Run Run Shaw Hospital | Hangzhou | 310018 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Jiangsu Cancer Hospital | Nanjing | 211100 | China |
| The Affiliated Hospital of Medical College Qingdao University | Qingdao | 266003 | China |
| Shanghai chest hospital | Shanghai | 200030 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| Liaoning cancer Hospital & Institute | Shenyang | 110042 | China |
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| The First Affiliated Hospital of Xian Jiao Tong University | Xi'an | 710061 | China |
| Zhejiang Cancer Hospital | Zhejiang | 310022 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care | Sarawak | Sarawak | 93586 | Malaysia |
| Hospital Sultan Ismail; Oncology | Johor Bahru | 81100 | Malaysia |
| Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi | Kuala Lumpur | 50586 | Malaysia |
| National Cancer Centre; Medical Oncology | Singapore | 169610 | Singapore |
| Kyungpook National University Medical Center | Daegu | 41404 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Chulalongkorn Hospital; Medical Oncology | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok | 10400 | Thailand |
| Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology | Bangkok | 10700 | Thailand |
| CHIANG MAI UNI HOSPITAL; FACULTY OF MEDICINE; Medical Oncology unit | Chiang Mai | 50200 | Thailand |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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