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
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)
1 other identifier
interventional
537
7 countries
92
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2019
Typical duration for phase_3
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedStudy Start
First participant enrolled
August 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedAugust 8, 2023
August 1, 2023
4.4 years
July 19, 2019
August 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tumor assessment
Progression-free survival (PFS) (assessed by the independent radiology review committee \[IRRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
Baseline until disease progression or death, whichever occurs first (up to approximately 24months)
Study Arms (2)
A
EXPERIMENTALHLX10 + chemotherapy (carboplatin nab paclitaxel)
B
PLACEBO COMPARATORPlacebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy
Interventions
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (92)
Oncology and Hematology Associates of Southwest Virginia
Roanoke, Virginia, 24014, 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
Liuchow, Guangxi, China
Liuzhou Worker's Hospital
Liuchow, 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
Related Publications (1)
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.
PMID: 38181795DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2019
First Posted
July 26, 2019
Study Start
August 14, 2019
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
August 8, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share