Spots Global Cancer Trial Database for A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy (Carboplatin-Nanoparticle Albumin Bound (Nab) Paclitaxel) in Patients With Stage IIIB/IIIC or IV NSCLC
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Trial Identification
Brief Title: A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy (Carboplatin-Nanoparticle Albumin Bound (Nab) Paclitaxel) in Patients With Stage IIIB/IIIC or IV NSCLC
Official Title: A Randomized, Double-Blind, Multicenter, Phase III Clinical Study of HLX10 (Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection) + Chemotherapy (Carboplatin Nanoparticle Albumin Bound (Nab)-Paclitaxel) vs Chemotherapy (Carboplatin Nab-Paclitaxel) as First-Line Therapy for Locally Advanced or Metastatic Squamous Non Small Cell Lung Cancer (NSCLC)
Study ID: NCT04033354
Conditions
Study Description
Brief Summary: This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10 + chemotherapy vs chemotherapy in subjects with locally advanced or metastatic squamous NSCLC who have not previously received systemic treatment. Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows: Arm A (HLX10 arm): HLX10 + chemotherapy (carboplatin nab paclitaxel) Arm B (placebo arm): Placebo + chemotherapy (carboplatin nab paclitaxel) The three stratification factors for randomization include: PD-L1 expression level (Tumor Proportion Scores \[TPS\]≥50%, 50%\>TPS≥1%, TPS\<1%), Asian population (yes or no), NSCLC stage (stage IIIB/IIIC or stage IV), and carboplatin AUC (5 or 6).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Oncology and Hematology Associates of Southwest Virginia, Roanoke, Virginia, United States
Anhui Medical University - The Second Hospital, Hefei, Anhui, China
Anhui Provincial Hospital, Hefei, Anhui, China
The First Affiliated Hospital Of Anhui Medical University, Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Beijing Chaoyang Hospital, Beijing, Beijing, China
Beijing Friendship Hospital, Beijing, Beijing, China
Peking University First Hospital, Beijing, Beijing, China
Daping Hospital, Chongqing, Chongqing, China
The Second Affiliated Hospital of Army Medical University,PLA, Chongqing, Chongqing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China
Fuzhou Pulmonary hospital of Fujian, Fuzhou, Fujian, China
Gansu Wuwei Tumour Hospital, Wuwei, Gansu, China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
The Fifth Affiliared Hospital Sun Yat-Sen University, Zhuhai, Guangdong, China
Liuzhou People's Hospital, Liuzhou, Guangxi, China
Liuzhou Worker's Hospital, Liuzhou, Guangxi, China
Guangxi Medical University Affiliated Tumor Hospital, Nanning, Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China
The Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, China
Affiliated Hospital of Hebei University, Baoding, Hebei, China
Cangzhou People's Hospital, Cangzhou, Hebei, China
Tangshan People's Hospital, Tangshan, Hebei, China
Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital), Ha'erbin, Heilongjiang, China
The fourth affiliated hospital of Harbin medical university, Ha'erbin, Heilongjiang, China
Jiamusi Cancer Hospital, Jiamusi, Heilongjiang, China
The Third Affiliated Hospital of Qiqihar Medical University, Qiqihar, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
Xuzhou Central Hospital, Xuzhou, Jiangsu, China
the First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
China-japan union hospital of jilin university, Changchun, Jilin, China
Jilin Province Cancer Hospital, Changchun, Jilin, China
Jilin Province People's Hospital, Changchun, Jilin, China
The first hospital of Jilin University, Changchun, Jilin, China
The second Hospital of Jilin University, Changchun, Jilin, China
Chifeng Municipal Hospital, Chifeng, Neimenggu, China
General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China
Shandong Cancer Hospital - Internal Medicine, Jinan, Shandong, China
Linyi City People Hospital, Linyi, Shandong, China
Shandong Linyi Tumor Hospital, Linyi, Shandong, China
Shanghai Eastern Hospital /Affliated Eastern Hospital of Ton, Shanghai, Shanghai, China
Shanghai Pulmonary Hospital, Shanghai, Shanghai, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Tianjin Medical University Cancer Hospital, Tianjin, Tianjin, China
Tianjin Medical University General Hospital, Tianjin, Tianjin, China
Yunnan cancer hospital, Kunming, Yunnan, China
Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, Zhejiang, China
The First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China
High Technology Hospital MedCenter LTD, Batumi, , Georgia
JSC Evex Clinics, St.Nikolozi Medical Centre, Kutaisi, , Georgia
Acad.F.Todua Medical Center - Research Institute of Clinical Medicine LTD, Tbilisi, , Georgia
Institute of Clinical Oncology LTD, Tbilisi, , Georgia
LTD Israeli-Georgian Medical Research Clinic HELSICORE, Tbilisi, , Georgia
Multiprofile Clinic Consilium Medula LTD, Tbilisi, , Georgia
New Hospitals LTD, Tbilisi, , Georgia
Scientific Research Center of Oncology LTD, Tbilisi, , Georgia
Uniwersytecki Szpital Kliniczny w Białymstoku, Białystok, , Poland
Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi, Łódź, , Poland
LLC "VitaMed ", Moscow, , Russian Federation
University Clinic of Headaches, Moscow, , Russian Federation
Budgetary Healthcare Institution of Omsk Region "C, Omsk, , Russian Federation
GBUZ Orenburg Regional Clinical Oncology Dispensar, Orenburg, , Russian Federation
First St. Petersburg State Medical University n. a. Pavlov, Saint Petersburg, , Russian Federation
Limited Liability Company "AV Medical Group", Saint Petersburg, , Russian Federation
LLC - Strategic Medical systems - Oncology - Oncology, Saint Petersburg, , Russian Federation
PMI "Evromedservice", Saint Petersburg, , Russian Federation
Volgograd Regional Clinical Oncology Dispensary, Volgograd, , Russian Federation
Ankara University Medical Faculty - Oncology, Ankara, , Turkey
Hacettepe University Medical Faculty - Medical Oncology, Ankara, , Turkey
Trakya University Medical Faculty, Edirne, , Turkey
Istanbul University Cerrahpasa Medical Faculty, Istanbul, , Turkey
Medipol Mega Hospital, Istanbul, , Turkey
Ege University Medical Faculty, İzmir, , Turkey
Izmir Medical Park Hospital - Medical Oncology, İzmir, , Turkey
Kocaeli University Research and Practice Hospital, Kocaeli, , Turkey
Necmettin Erbakan University Meram Medical Faculty, Konya, , Turkey
Inonu University Turgut Ozal Medical Center, Malatya, , Turkey
Komunalna ustanova "Chernivets, Chernivtsi, , Ukraine
Komunalnyi zaklad Miska bahato, Dnipro, , Ukraine
Komunalne nekomertsiine pidpry, Kharkiv, , Ukraine
PE PMC "Acinus", Kirovohrad, , Ukraine
Medychnyi tsentr "Mriya Med-Servis", Kryvyi Rih, , Ukraine
Limited Liability Company "Medical Center "Verum", Kyiv, , Ukraine
Komunalne pidpryiemstvo "Volynskyi oblasnyi medychnyi tsentr onkolohii" Volynskoyi oblasnoyi rady, Luts'k, , Ukraine
Medychnyi tsentr "Onkolaif" LL, Zaporizhzhia, , Ukraine
Zaporozhye Regional Clinical O, Zaporizhzhia, , Ukraine
Contact Details
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