A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC
A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Efficacy and Safety of HLX10 in Combination With Chemotherapy in Previously Untreated Patients With ES-SCLC
1 other identifier
interventional
585
5 countries
5
Brief Summary
This is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell Lung Cancer. 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-Etoposide) ; Arm B (placebo arm): Placebo + chemotherapy (Carboplatin-Etoposide); The three stratification factors for randomization include: PD-L1 expression level (negative, positive, not available), Brain metastasis (yes versus no), Age (≥ 65 years versus \< 65 years)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2019
Longer than P75 for phase_3
5 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
August 17, 2019
CompletedFirst Posted
Study publicly available on registry
August 21, 2019
CompletedStudy Start
First participant enrolled
September 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2024
CompletedResults Posted
Study results publicly available
December 9, 2025
CompletedDecember 9, 2025
December 1, 2025
4.7 years
August 17, 2019
April 9, 2025
December 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
OS
Overall survival (OS)
The period from randomization through death regardless of causality (up to approximately 56 months)
Secondary Outcomes (3)
Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1
From randomization initiation to the first documentation of PD or death regardless of causality, whichever occurs first (up to approximately 56 months).
Objective Response Rate
From baseline until PR or CR, whichever occurs first (up to approximately 56 months)
Duration of Response
From the first documentation of response (CR or PR) through the first documentation of PD or death, whichever occurs first (up to approximately 56 months).
Study Arms (2)
A
EXPERIMENTALHLX 10+chemotherapy (Carboplatin-Etoposide)
B
PLACEBO COMPARATORPlacebo+chemotherapy (Carboplatin-Etoposide)
Interventions
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
- No prior systemic therapy for ES-SCLC
- Major organs are functioning well
- Participant must keep contraception
You may not qualify if:
- Histologically or cytologically confirmed mixed SCLC.
- Known history of severe allergy to any monoclonal antibody.
- Known hypersensitivity to carboplatin or etoposide.
- Pregnant or breastfeeding females.
- Patients with a known history of psychotropic drug abuse or drug addiction.
- 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 (5)
Institute for Personalized Medicine
Tbilisi, Georgia
Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi
Lodz, Poland
Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk, Russia
Medipol Mega Hospital
Istanbul, Turkey (Türkiye)
Komunalnyi zaklad Miska bahato
Dnipropetrovsk, Ukraine
Related Publications (3)
Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.
PMID: 40932107DERIVEDZhu Y, Liu K, Qin Q, Zhu H. Serplulimab plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: A cost-effectiveness analysis. Front Immunol. 2023 Jan 4;13:1044678. doi: 10.3389/fimmu.2022.1044678. eCollection 2022.
PMID: 36685541DERIVEDCheng Y, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Dvorkin M, Shi J, Pan Z, Shi J, Wang X, Bai Y, Melkadze T, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Kang W, Wang Q, Zhu J; ASTRUM-005 Study Group. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer: The ASTRUM-005 Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1223-1232. doi: 10.1001/jama.2022.16464.
PMID: 36166026DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Fan Zhang
- Organization
- ShanghaiHenliusBiotech
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2019
First Posted
August 21, 2019
Study Start
September 12, 2019
Primary Completion
May 7, 2024
Study Completion
May 7, 2024
Last Updated
December 9, 2025
Results First Posted
December 9, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share