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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
585 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Serplulimab + CE | 389 | 15.4 months | 0.63 (0.49 to 0.82) | - | link |
| Placebo + CE | 196 | 10.9 months |
Shares Shanghai Henlius Biotech, Serplulimab, Extensive-stage small-cell lung cancer, Small-cell lung cancer.
Shares CAPSTONE-1, Platinum + etoposide (EP / CE), Extensive-stage small-cell lung cancer, Small-cell lung cancer.
Shares Shanghai Henlius Biotech, Serplulimab, Small-cell lung cancer, Immune checkpoint inhibitors.
Shares Shanghai Henlius Biotech, Serplulimab, Small-cell lung cancer, Immune checkpoint inhibitors.
Shares CAPSTONE-1, Platinum + etoposide (EP / CE), Extensive-stage small-cell lung cancer, Small-cell lung cancer.
Shares Shanghai Henlius Biotech, Serplulimab, Small-cell lung cancer, Immune checkpoint inhibitors.
Shares Shanghai Henlius Biotech, Serplulimab, Small-cell lung cancer, Immune checkpoint inhibitors.
Shares Shanghai Henlius Biotech, Extensive-stage small-cell lung cancer, Small-cell lung cancer.