Consolidation Serplulimab Following Hypo-cCRT Improves Outcomes in Limited-Stage Small Cell Lung Cancer
Key Clinical Summary:
- Design/Population: The phase 2ASTRUM-LC01 trial was a multicenter, single-arm study evaluating serplulimab consolidation after concurrent hypofractionated chemoradiotherapy in 55 patients with limited-stage small cell lung cancer who responded to induction therapy, with comparison to a historical cohort using IPTW adjustment.
- Key Outcomes: At 29.4 months median follow-up, median progression-free survival was 27.5 months, and median overall survival was not reached. Compared with historical controls, serplulimab consolidation significantly improved PFS and OS. Grade ≥3 immune-related AEs occurred in 21.8%, with grade ≥3 pneumonitis and esophagitis.
- Clinical Relevance: Serplulimab consolidation after hypofractionated chemoradiotherapy shows promising survival benefit with manageable toxicity in LS-SCLC, supporting this approach as a potential new post-chemoradiotherapy strategy, pending confirmation in randomized trials.
Updated results from the phase 2 ASTRUM-LC01 trial demonstrate that consolidation serplulimab following concurrent hypofractionated chemoradiotherapy (Hypo-cCRT) improves survival with manageable safety among patients with limited-stage small cell lung cancer (LS-SCLC).
These results were presented at the 2026 European Lung Cancer Congress in Copenhagen, Denmark, by Yuqi Wu, MD, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
In this multicenter, single-arm study, researchers enrolled 55 patients who achieved response after 4 cycles of platinum-etoposide plus concurrent hypofractionated radiotherapy (45 Gy or 36 Gy in 15 fractions) to receive serplulimab consolidation. Primary end points included progression-free survival (PFS), overall survival (OS), and safety. Survival outcomes were compared against a historical cohort of patients treated with Hypo-cCRT in a phase 3 trial (n = 241). Inverse probability of treatment weighting (IPTW) was used to adjust for baseline differences.
At a median follow-up of 29.4 months in the serplulimab arm, median PFS was 27.5 months with 1- and 2-year PFS rates of 63.6% and 54% , respectively. Median OS was not reached with 1- and 2-year OS rates of 92.7% and 78.9%, respectively. After IPTW adjustment, serplulimab consolidation significantly improved PFS (hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.41 to 0.90; P = .014) and OS (HR, 0.48; 95% CI, 0.27 to 0.85; P = .011) compared with hypofractionated chemoradiotherapy alone.
Grade 3/4 immune-related adverse events were reported in 21.8% of patients and most frequently included radiation pneumonitis (7.3%) and esophagitis (1.8%). No deaths were reported.
Results “demonstrated that serplulimab consolidation following Hypo-cCRT yields compelling survival benefits with a manageable safety,” concluded Dr Wu et al. “The significant OS improvement over control group support serplulimab after Hypo-cCRT as a potential therapeutic strategy, warranting validation in randomized controlled trials.”
Source:
Wu Y. Deng L, Cao J, et al. Serplulimab consolidation after concurrent hypofractionated chemoradiotherapy for limited-stage small cell lung cancer. Presented at European Lung Cancer Congress. March 25 - 28, 2026. Copenhagen, Denmark. 411P.
