OnCo
trialsTrialPositive

ASTRUM-005

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.

OS 15.4 vs 10.9 months (HR 0.63). Approved in China (2022), EU (February 2025), UK and India (2025). A US bridging study versus atezolizumab (ASTRIDE) has completed enrolment.

Setting
First-line ES-SCLC: serplulimab + carboplatin-etoposide vs placebo + carboplatin-etoposide
Phase
Phase 3
Sponsor
Henlius
Registry
NCT04063163
Headline result
OS 15.4 vs 10.9 months, HR 0.63.
Reported
2022
Enrolled
585
Replication
Consistent with IMpower133 and CASPIAN; cross-trial magnitude differences may reflect population and control-arm differences rather than drug differences.

Outcomes

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In plain words
What these results mean for people, not percentages
585 people took part
Overall survivalprimarysurvival endpoint
  • Median 15.4 vs 10.9 months with Serplulimab + CE compared with Placebo + CE; about 4.5 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 37 percent lower chance of the event at any given time (hazard ratio 0.63, likely range 0.49 to 0.82).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
  • These results apply to the people the trial enrolled: First-line ES-SCLC: serplulimab + carboplatin-etoposide vs placebo + carboplatin-etoposide. People in a different situation may not see the same effect.

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 participants enrolled.

Overall survivalprimary
HR 0.63 (0.49–0.82)
Serplulimab + CE
15.4 mo
Placebo + CE
10.9 mo
Source
EndpointArmnValueHR (95% CI)pSource
Overall survivalprimarySerplulimab + CE38915.4 months0.63 (0.49–0.82)—link
Placebo + CE19610.9 months
Replication
Consistent with IMpower133 and CASPIAN; cross-trial magnitude differences may reflect population and control-arm differences rather than drug differences.

Connected

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Pages like this

not linked directly; found by shared links

cancers

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Small-cell lung cancer

drugs

2
Not mapped hereCytotoxic regimen
Platinum + etoposide (EP / CE)
Under reviewMonoclonal antibody (anti-PD-1)
Serplulimab · Hansizhuang / Hetronifly