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Brief Title: Comparison of Efficacy and Safety of Anti-PD-1 Antibody BGB-A317 Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With NSCLC
Official Title: A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti-PD1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen
Study ID: NCT03358875
Brief Summary: The purpose of this study is to show that BGB-A317 will improve overall survival in participants with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or third-line treatment setting.
Detailed Description: This is a randomized, open-label, multicenter Phase 3 study in adult participants with histologically confirmed, locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
NOB - Núcleo de Oncologia da Bahia, Salvador, Bahia, Brazil
Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará, Fortaleza, Ceará, Brazil
Hospital Evangélico de Cachoeiro de Itapemirim, Cachoeiro De Itapemirim, Espírito Santo, Brazil
INCA - Instituto Nacional de Câncer, Rio De Janeiro, Rio De Janiero, Brazil
Hospital de Caridade de Ijuí, Ijuí, Rio Grande Do Sul, Brazil
Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Câncer de Barretos - Fundação Pio XII, Barretos, Sao Paulo, Brazil
Fundação Doutor Amaral Carvalho, Jaú, Sao Paulo, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo Andre, Sao Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto, Sao Paulo, Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, São Paulo, Sao Paulo, Brazil
MHAT "Dr. Tota Venkova", AD, Gabrovo, , Bulgaria
Acibadem City Clinic Tokuda Hospital Ead, Sofia, , Bulgaria
Anhui Provincial Hospital, Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Chinese PLA General Hospital, Beijing, Beijing, China
Beijing Chest Hospital, Capital Medical University, Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences City: Beijing, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Beijing Cancer Hospital, Beijin, Beijing, China
Daping Hospital of The 3rd Military University, Chongqing, Chongqing, China
Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong, China
Guangzhou Institute of Respiratory, Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College, Shantou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
The Affiliated Hospital of Zunyi Medical College, Zunyi, Guizhou, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hubei cancer hospital, Wuhan, Hubei, China
Changsha Central Hospital, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Xiangya Hospital of Central South University, Changsha, Hunan, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
Nantong Tumor Hospital, Nantong, Jiangsu, China
The Second Hospital Affiliated to Suzhou University, Suzhou, Jiangsu, China
Xuzhou Central Hospital, Xuzhou, Jiangsu, China
Jiangxi cancer hospital, Nanchang, Jiangxi, China
Jilin Cancer Hospital, Changchun, Jilin, China
The First Hospital of Jilin University, Changchun, Jilin, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
Jinan Central Hospital, Jinan, Shandong, China
Linyi Cancer Hospital, Linyi, Shandong, China
Shanghai Pulmonary Hospital, Shanghai, Shanghai, China
Ruijin hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
First Affiliated Hospital of Xi'an Jiaotong University, Xian, Shanxi, China
Sichuan Provincial People's Hospital, Chengdu, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, China
Yunnan Cancer Hospital, Kunming, Yunnan, China
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, , China
Tongji Hospital of Tongji Medical College Huazhong University of Science Technology, Wuhan, , China
Hospital of Lithuanian University of Health Sciences Kaunas Clinics branch Oncology Hospital, Kaunas, , Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas, , Lithuania
National Cancer Institute, Vilnius, , Lithuania
Investigacion Onco Farmaceutica (OncoTech), La Paz, Baja California Sur, Mexico
Health Pharma Professional Research S.A. de C.V., Mexico, Distrito Federal, Mexico
Fundacion Rodolfo Padilla Padilla, A.C., León, Guanajuato, Mexico
Accelerium S de RL de CV, Monterrey, Nuevo León, Mexico
Auckland City Hospital, Grafton, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Tauranga Hospital, Tauranga, , New Zealand
SP Zespol Gruzlicy i Chorob Pluc w Olsztynie, Olsztyn, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna, Łódź, , Poland
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary", Arkhangel'sk, , Russian Federation
Irkutsk Regional Oncology Dispensary, Irkutsk, , Russian Federation
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow, , Russian Federation
"VitaMed" LLC, Moscow, , Russian Federation
BHI of Omsk region "Clinical Oncology Dispensary", Omsk, , Russian Federation
Private Medical Institution "Evromedservis", Saint Petersburg, , Russian Federation
Pavlov First Saint Petersburg State Medical University, Saint Petersburg, , Russian Federation
FSBI of higher education"Ogarev Mordovia State University", Saransk, , Russian Federation
Fakultna nemocnica s poliklinikou F.D. Roosevelta, Banska Bystrica, , Slovakia
Nemocnica na okraji mesta, n.o., Partizanske, , Slovakia
POKO Poprad s.r.o., Poprad, , Slovakia
Acibadem Adana Hospital, Adana, , Turkey
Hacettepe University, Ankara, , Turkey
Trakya University Medical Faculty, Edirne, , Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty, Istanbul, , Turkey
Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital, Istanbul, , Turkey
Istanbul Medeniyet Uni Goztepe Training&Res Hosp, Istanbul, , Turkey
Kocaeli Universitesi Tip Fakultesi, Kocaeli, , Turkey
Inonu Uni. Med. Fac., Malatya, , Turkey
Namik Kemal University, Tekirdağ, , Turkey
Name: Caicun Zhou, PhD
Affiliation: Shanghai Pulmonary Hospital, Shanghai, China
Role: PRINCIPAL_INVESTIGATOR