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Clinical trial · no report yet · Phase 3
ASTRUM-005
A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC
- NCT04063163 ↗
- Completed
- Shanghai Henlius Biotech
- Standard
We haven't built an HCP commentary report on ASTRUM-005 (HLX10 and carboplatin and etoposide in Extensive Stage Small Cell Lung Cancer) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on ASTRUM-005 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 11 | |
| Podcasts | 2 | |
| YouTube | 1 |
The trial
ClinicalTrials.gov- Official title
- 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
- Phase
- Phase 3
- Status
- Completed
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Interventions
- HLX10; carboplatin and etoposide; placebo
- Arms
- A · Experimental
- B · Placebo comparator
- Enrollment
- 585
- Primary outcomes
- OS
- Sponsor
- Shanghai Henlius Biotech
- Start
- Sep 12, 2019
- Primary completion
- May 7, 2024
- Results posted
- Yes
- Registry record
- NCT04063163 · updated Dec 9, 2025
Publications
linked from the registry- Liu 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. PubMed 42240984
- 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. PubMed 40932107
- Zhu 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. PubMed 36685541
- Cheng 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. PubMed 36166026