Sintilimab plus concurrent chemoradiotherapy for treatment of locally advanced small cell lung cancer (SINCE-01): a phase II clinical trial - PubMed
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- #small cell lung cancer
- #sintilimab
- #chemoradiotherapy
- Sintilimab plus concurrent chemoradiotherapy (CCRT) was evaluated in a phase II trial (SINCE-01) for limited-stage small cell lung cancer (LS-SCLC).
- The single-arm study involved 22 LS-SCLC patients who received sintilimab with chemotherapy and thoracic radiation (45 Gy in 30 fractions).
- Median progression-free survival (PFS) was 29.6 months, with 12- and 24-month PFS rates of 72.7% and 54.5%, respectively.
- Median overall survival (OS) was 40.6 months, with 12- and 24-month OS rates of 95.5% and 72.7%, respectively.
- Objective response rate (ORR) was 95.5%, indicating high tumor response.
- Safety profile was manageable; common grade 3-4 adverse events were hematologic (e.g., neutropenia, thrombocytopenia), with pneumonitis in three patients and no treatment-related deaths.
- Elevated HLA-I+ tumor cell expression correlated with longer PFS, suggesting a potential predictive biomarker for efficacy.