# ASTRUM-005

Source: https://onco.cc/trials/astrum-005/  
OnCo record `astrum-005` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In ASTRUM-005, a Chinese PD-1 antibody produced the longest first-line survival of the chemo-immunotherapy trials; it is now approved in Europe and the UK but not yet in the US.

## Summary

ASTRUM-005, trial NCT04063163 sponsored by Henlius and reported in 2022, showed that the Chinese PD-1 antibody serplulimab added to first-line carboplatin and etoposide in extensive-stage small-cell lung cancer produced the longest survival of the chemo-immunotherapy trials, and it is now approved in Europe, the United Kingdom and India but not yet in the United States. It randomised 585 patients and met its primary overall survival endpoint, leading to approval in China in 2022 and in the European Union in February 2025, while a US bridging study against atezolizumab, ASTRIDE, has completed enrolment. OnCo links it to small-cell lung cancer, serplulimab, the platinum-etoposide record, Shanghai Henlius Biotech, Ying Cheng, Jilin Cancer Hospital and CAPSTONE-1. Whether cross-trial differences in effect size reflect drug or population is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT04063163
- Phase: 3
- Setting: First-line ES-SCLC: serplulimab + carboplatin-etoposide vs placebo + carboplatin-etoposide
- Sponsor: Henlius
- Enrolled: 585
- Result: OS 15.4 vs 10.9 months, HR 0.63.
- Outcomes: Overall survival: Serplulimab + CE 15.4 months vs Placebo + CE 10.9 months, HR 0.63
- Replication: Consistent with IMpower133 and CASPIAN; cross-trial magnitude differences may reflect population and control-arm differences rather than drug differences.

## Sources

- ClinicalTrials.gov NCT04063163: https://clinicaltrials.gov/study/NCT04063163

## Connected records

- cancers: [Extensive-stage small-cell lung cancer](https://onco.cc/cancers/extensive-stage-sclc/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Platinum + etoposide (EP / CE)](https://onco.cc/drugs/platinum-etoposide/), [Serplulimab](https://onco.cc/drugs/serplulimab/)
- companies: [Shanghai Henlius Biotech](https://onco.cc/companies/henlius/)
- people: [Ying Cheng](https://onco.cc/people/cheng-ying/)
- key papers: [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](https://onco.cc/key-papers/paper-astrum-005-jama-2022/)
- institutions: [Jilin Cancer Hospital](https://onco.cc/institutions/jilin-cancer-hospital/)
- trials: [CAPSTONE-1](https://onco.cc/trials/capstone-1/)

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