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
NCT ID: NCT04033354
Last Updated: 2023-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
537 participants
INTERVENTIONAL
2019-08-14
2023-12-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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A
HLX10 + chemotherapy (carboplatin nab paclitaxel)
HLX10
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
carboplatin and nab paclitaxel
chemotherapeutics
B
Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy
carboplatin and nab paclitaxel
chemotherapeutics
Placebo
Placebo
Interventions
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HLX10
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
carboplatin and nab paclitaxel
chemotherapeutics
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. No known sensitizing EGFR mutations or ALK, ROS1 gene rearrangements.
3. Major organs are functioning well
4. Participant must keep contraception
5. Patients with prior denosumab use who can agree to switch to bisphosphonate therapy for bone metastases in the study.
Exclusion Criteria
2. Patients with known history of severe hypersensitivity to any monoclonal antibody.
3. Patients with known hypersensitivity to any compositions of carboplatin or nab-paclitaxel.
4. Pregnant or breastfeeding females.
5. Patients with a known history of psychotropic drug abuse or drug addiction; or a history of alcohol abuse.
6. Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.
18 Years
ALL
No
Sponsors
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Shanghai Henlius Biotech
INDUSTRY
Responsible Party
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Locations
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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 Municipality, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Daping Hospital
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Army Medical University,PLA
Chongqing, Chongqing Municipality, 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)
Harbin, Heilongjiang, China
The fourth affiliated hospital of Harbin medical university
Harbin, 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 Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 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
Bialystok, , Poland
Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi
Lodz, , Poland
LLC "VitaMed "
Moscow, , Russia
University Clinic of Headaches
Moscow, , Russia
Budgetary Healthcare Institution of Omsk Region "C
Omsk, , Russia
GBUZ Orenburg Regional Clinical Oncology Dispensar
Orenburg, , Russia
First St. Petersburg State Medical University n. a. Pavlov
Saint Petersburg, , Russia
Limited Liability Company "AV Medical Group"
Saint Petersburg, , Russia
LLC - Strategic Medical systems - Oncology - Oncology
Saint Petersburg, , Russia
PMI "Evromedservice"
Saint Petersburg, , Russia
Volgograd Regional Clinical Oncology Dispensary
Volgograd, , Russia
Ankara University Medical Faculty - Oncology
Ankara, , Turkey (Türkiye)
Hacettepe University Medical Faculty - Medical Oncology
Ankara, , Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Medipol Mega Hospital
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Izmir Medical Park Hospital - Medical Oncology
Izmir, , Turkey (Türkiye)
Kocaeli University Research and Practice Hospital
Kocaeli, , Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty
Konya, , Turkey (Türkiye)
Inonu University Turgut Ozal Medical Center
Malatya, , Turkey (Türkiye)
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
Lutsk, , Ukraine
Medychnyi tsentr "Onkolaif" LL
Zaporizhzhia, , Ukraine
Zaporozhye Regional Clinical O
Zaporizhzhia, , Ukraine
Countries
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References
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Zhou C, Hu Y, Arkania E, Kilickap S, Ying K, Xu F, Wu L, Wang X, Viguro M, Makharadze T, Sun H, Luo F, Shi J, Zang A, Pan Y, Chen Z, Jia Z, Kuchava V, Lu P, Zhang L, Cheng Y, Kang W, Wang Q, Yu H, Li J, Zhu J; ASTRUM-004 Investigators. A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004). Cancer Cell. 2024 Feb 12;42(2):198-208.e3. doi: 10.1016/j.ccell.2023.12.004. Epub 2024 Jan 4.
Other Identifiers
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HLX10-004-NSCLC303
Identifier Type: -
Identifier Source: org_study_id
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