- Design
- Randomised phase 2 trial
- Population
- 41 patients with untreated limited-stage small cell lung cancer in China
- Primary outcome
- 1-year progression-free survival
- Effect
- 65.5% vs 47.4% (p = 0.029); median PFS 24.0 vs 11.8 months
A randomised phase 2 trial in China enrolled 41 patients with untreated limited-stage small cell lung cancer. One arm received camrelizumab with etoposide-platinum induction, then concurrent chemoradiotherapy and camrelizumab consolidation; the other received induction chemotherapy and chemoradiotherapy without immunotherapy.
At a median follow-up of 32 months, 1-year progression-free survival was 65.5% with camrelizumab and 47.4% without. Median PFS was 24.0 against 11.8 months, and median overall survival was not reached against 23.9 months. Severe immune-related events occurred in 4.8%, and radiation pneumonitis rates were similar.
The control arm lacks immunotherapy consolidation, which is now standard after chemoradiotherapy, so this does not show camrelizumab beats current care. With 41 patients, it is a signal for a phase 3 trial. The biomarker findings are exploratory. Camrelizumab's regulatory status in India is not known.
- Keep consolidation immunotherapy after chemoradiotherapy as the current standard in limited-stage SCLC
- Do not add induction immunotherapy outside a trial on this evidence
- Monitor for immune-related toxicity and radiation pneumonitis when combining immunotherapy with thoracic radiotherapy
- Watch for phase 3 data comparing induction-plus-consolidation against consolidation alone
Why it matters
It raises the question of whether immunotherapy should start before chemoradiotherapy, not only after it.
Don't overread it
The control arm had no immunotherapy consolidation, which is the current standard, and only 41 patients were enrolled.
The statistics, in plain English
With 41 patients, each arm had about 20, so a few events either way would move the percentages a lot. A p-value of 0.029 on a small phase 2 trial needs confirmation before it changes anything.
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