Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin and etoposide | Drug | — | UNRESOLVED |
| HLX10 | Drug | Serplulimab | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- HLX 10+chemotherapy (Carboplatin-Etoposide)
- interventionNames
- Drug: HLX10
- Drug: carboplatin and etoposide
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- Placebo+chemotherapy (Carboplatin-Etoposide)
- interventionNames
- Drug: carboplatin and etoposide
- Drug: placebo
Primary outcomes (1)
- measure
- OS
- timeFrame
- The period from randomization through death regardless of causality (up to approximately 56 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- DERIVEDLiu J, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Shi J, Pan Z, Shi J, Wang X, Bai Y, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Yu H, Li J, Yang X, Wang Q, Zhu J; ASTRUM-005 Study Group. First-Line Serplulimab in Extensive-Stage Small Cell Lung Cancer: Secondary Analysis of the ASTRUM-005 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2026 Jun 4:e261645. doi: 10.1001/jamaoncol.2026.1645. Online ahead of print. PMID 42240984
- DERIVEDWang 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 40932107
- DERIVEDZhu 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 36685541
- DERIVEDCheng 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 36166026