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
- Conditions
- Squamous Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT04033354
- Lead Sponsor
- Shanghai Henlius Biotech
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 537
- Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV (AJCC Edition 8) squamous NSCLC where surgery or radiotherapy cannot be performed.
- No known sensitizing EGFR mutations or ALK, ROS1 gene rearrangements.
- Major organs are functioning well
- Participant must keep contraception
- Patients with prior denosumab use who can agree to switch to bisphosphonate therapy for bone metastases in the study.
- Patients with histologically non-squamous NSCLC. Mixed tumors will be classified according to the primary cell type. Patients do not meet the requirements for enrollment if small cell components and neuroendocrine carcinoma components are present. For non-small cell histology, patients meet the requirements for enrollment if squamous components (e.g., adenosquamous) are present.
- Patients with known history of severe hypersensitivity to any monoclonal antibody.
- Patients with known hypersensitivity to any compositions of carboplatin or nab-paclitaxel.
- Pregnant or breastfeeding females.
- Patients with a known history of psychotropic drug abuse or drug addiction; or a history of alcohol abuse.
- Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A carboplatin and nab paclitaxel HLX10 + chemotherapy (carboplatin nab paclitaxel) B Placebo Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy B carboplatin and nab paclitaxel Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy A HLX10 HLX10 + chemotherapy (carboplatin nab paclitaxel)
- Primary Outcome Measures
Name Time Method tumor assessment Baseline until disease progression or death, whichever occurs first (up to approximately 24months) Progression-free survival (PFS) (assessed by the independent radiology review committee \[IRRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (92)
Anhui Medical University - The Second Hospital
🇨🇳Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Daping Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Fuzhou Pulmonary hospital of Fujian
🇨🇳Fuzhou, Fujian, China
Gansu Wuwei Tumour Hospital
🇨🇳Wuwei, Gansu, China
The Fifth Affiliared Hospital Sun Yat-Sen University
🇨🇳Zhuhai, Guangdong, China
Liuzhou Worker's Hospital
🇨🇳Liuzhou, Guangxi, China
Tangshan People's Hospital
🇨🇳Tangshan, Hebei, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
the First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
JSC Evex Clinics, St.Nikolozi Medical Centre
🇬🇪Kutaisi, Georgia
LLC "VitaMed "
🇷🇺Moscow, Russian Federation
Oncology and Hematology Associates of Southwest Virginia
🇺🇸Roanoke, Virginia, United States
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital Of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Beijing Chaoyang Hospital
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital of Army Medical University,PLA
🇨🇳Chongqing, Chongqing, China
Fujian Provincial Cancer Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Liuzhou People'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
Cangzhou People's Hospital
🇨🇳Cangzhou, Hebei, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
Jiamusi Cancer Hospital
🇨🇳Jiamusi, Heilongjiang, China
Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital)
🇨🇳Ha'erbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
The fourth affiliated hospital of Harbin medical university
🇨🇳Ha'erbin, Heilongjiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The Third Affiliated Hospital of Qiqihar Medical University
🇨🇳Qiqihar, Heilongjiang, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Jilin Province Cancer Hospital
🇨🇳Changchun, Jilin, China
China-japan union hospital of jilin university
🇨🇳Changchun, Jilin, China
Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
The second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
The first hospital of Jilin University
🇨🇳Changchun, Jilin, China
Chifeng Municipal Hospital
🇨🇳Chifeng, Neimenggu, China
Shandong Linyi Tumor Hospital
🇨🇳Linyi, Shandong, China
Linyi City People Hospital
🇨🇳Linyi, Shandong, China
Shandong Cancer Hospital - Internal Medicine
🇨🇳Jinan, Shandong, China
Shanghai Eastern Hospital /Affliated Eastern Hospital of Ton
🇨🇳Shanghai, Shanghai, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
Tianjin Medical University Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
The Second Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, 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
High Technology Hospital MedCenter LTD
🇬🇪Batumi, 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
Uniwersytecki Szpital Kliniczny w Białymstoku
🇵🇱Białystok, Poland
Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi
🇵🇱Łódź, Poland
University Clinic of Headaches
🇷🇺Moscow, Russian Federation
Scientific Research Center of Oncology LTD
🇬🇪Tbilisi, Georgia
Budgetary Healthcare Institution of Omsk Region "C
🇷🇺Omsk, Russian Federation
Limited Liability Company "AV Medical Group"
🇷🇺Saint Petersburg, Russian Federation
GBUZ Orenburg Regional Clinical Oncology Dispensar
🇷🇺Orenburg, Russian Federation
First St. Petersburg State Medical University n. a. Pavlov
🇷🇺Saint Petersburg, Russian Federation
LLC - Strategic Medical systems - Oncology - Oncology
🇷🇺Saint Petersburg, Russian Federation
PMI "Evromedservice"
🇷🇺Saint Petersburg, Russian Federation
Ankara University Medical Faculty - Oncology
🇹🇷Ankara, Turkey
Trakya University Medical Faculty
🇹🇷Edirne, Turkey
Volgograd Regional Clinical Oncology Dispensary
🇷🇺Volgograd, Russian Federation
Hacettepe University Medical Faculty - Medical Oncology
🇹🇷Ankara, 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
Komunalnyi zaklad Miska bahato
🇺🇦Dnipro, Ukraine
Komunalna ustanova "Chernivets
🇺🇦Chernivtsi, 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
Peking University First Hospital
🇨🇳Beijing, Beijing, China