- Design
- Phase 3, open-label, randomised trial, prespecified interim analysis
- Population
- 451 patients with SCLC progressing after platinum-based therapy
- Primary outcome
- Overall survival
- Effect
- Median 13.3 vs 9.4 months, HR 0.46 (0.35–0.62); response 59.1% vs 9.7%
TAISHAN-302, published in NEJM on 12 September, randomised 451 patients with small-cell lung cancer that had progressed after first-line platinum chemotherapy to tambotatug pelitecan (Tam-Peli), an antibody–drug conjugate targeting the checkpoint molecule B7-H3, or topotecan. It was open-label, run in China, with overall survival as the primary endpoint; these are interim results.
Median overall survival was 13.3 months with Tam-Peli versus 9.4 months with topotecan (HR 0.46, 95% CI 0.35–0.62). Progression-free survival was 7.4 versus 2.8 months (HR 0.29), and confirmed response 59.1% versus 9.7%. Grade 3 or higher adverse events were less common with Tam-Peli (55.4% vs 77.9%).
Second-line options in SCLC have been poor, and topotecan is a weak and toxic comparator. A survival gain of this size with less severe toxicity would change the second-line standard. But this is one interim analysis in one country, the drug is not approved by the FDA, EMA or CDSCO, and results need confirmation in other populations.
- Consider referral to trials of B7-H3 agents for patients relapsing after platinum
- Keep topotecan or other standard options as current practice until approval
- Discuss the evidence with patients who ask, including its interim, single-country nature
- Watch for regulatory filings and data in non-Chinese populations
- In India, the drug is not available outside trials
Why it matters
It is the largest survival gain reported in second-line small-cell lung cancer for decades.
Don't overread it
These are interim results from an open-label trial in China, and the drug has no regulatory approval yet.
The statistics, in plain English
A hazard ratio of 0.46 means the risk of death at any point was about half with Tam-Peli; the upper limit of 0.62 still indicates a large benefit. Interim analyses stopped on benefit can overestimate the effect, and open-label designs can bias investigator-assessed response and progression.
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