2023 World Conference on Lung Cancer (Posters)-P2.14. A Phase II Study of Sintilimab Combined with Concurrent Chemoradiotherapy in Patients with Limited-Stage Small Cell Lung Cancer:SINCE-01 Trial

P2.14. A Phase II Study of Sintilimab Combined with Concurrent Chemoradiotherapy in Patients with Limited-Stage Small Cell Lung Cancer:SINCE-01 Trial - PDF(Slides)

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A Phase II study, called the SINCE-01 Trial, aimed to investigate the effectiveness and safety of combining the drug sintilimab with concurrent chemoradiotherapy in patients with limited-stage small cell lung cancer (LD-SCLC). The standard treatment for LD-SCLC is concurrent chemoradiotherapy, but many patients experience local recurrence or distant metastasis within a year, and the median progression-free survival is only around 12 months. Tumor immune checkpoint therapy has shown significant advancements in recent years.<br /><br />The study enrolled 25 patients who received concurrent radiotherapy, chemotherapy, and immunotherapy. The primary endpoint was progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), duration of response (DOR), overall survival (OS), and safety.<br /><br />By March 2023, with a median follow-up time of 24 months, neither PFS nor OS had been reached. The 12-month and 24-month PFS rates were 75% and 59.1%, respectively, while the 12-month and 24-month OS rates were 90% and 69.3%, respectively. The objective response rate was 95%, with 6 cases of complete response, 13 cases of partial response, and 1 case of stable disease. The disease control rate was 100%, and the median duration of response was not reached.<br /><br />The safety profile of the treatment was manageable, with no unexpected adverse events reported. The incidence of grade 3 adverse events was 45%, mainly including leukopenia, neutropenia, and thrombocytopenia. The incidence of immune-related adverse events was 35%, with pneumonia, liver function damage, hyperglycemia, and hypothyroidism being the main adverse effects.<br /><br />In conclusion, the combination of sintilimab with concurrent chemoradiotherapy showed promising results and a tolerable safety profile for patients with limited-stage small cell lung cancer. Long-term efficacy is still being followed up. The findings of this study were presented at the 2023 World Conference on Lung Cancer.

Asset Subtitle

Wei Huang

Meta Tag

Speaker Wei Huang

Topic SCLC & Neuroendocrine Tumors: First Line Therapy

Keywords

Phase II study

SINCE-01 Trial

sintilimab

concurrent chemoradiotherapy

limited-stage small cell lung cancer

LD-SCLC

progression-free survival

objective response rate

overall survival

safety profile