Phase 3
Completed N=585
A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC
Source: ClinicalTrials.gov NCT04063163 ↗Enrolled (actual)
585
Serious AEs
37.1%
Results posted
Dec 2025
Primary outcomePrimary: OS — 15.77; 11.10 month — p=<0.001
◆ Published Evidence
Highly cited
462citations · ~116 / year
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.
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)
Linked Publications (4)
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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.
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Serplulimab plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: A cost-effectiveness analysis.
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Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients.
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First-Line Serplulimab in Extensive-Stage Small Cell Lung Cancer: Secondary Analysis of the ASTRUM-005 Phase 3 Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY OS |
15.77; 11.10 | <0.001 sig |
| SECONDARY Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1 |
5.82; 4.34 | 0.001 sig |
| SECONDARY Objective Response Rate |
268; 115 | — |
| SECONDARY Duration of Response |
6.80; 4.17 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04063163) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.