ArticleJournal of thoracic disease2026
A single-arm, single-center phase II clinical study of concurrent brain radiotherapy combined with tislelizumab and chemotherapy in patients with small-cell lung cancer and brain metastases.
Article in Journal of thoracic disease, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Brain metastases from small cell lung cancer (SCLC) are characterized by high malignancy and poor prognosis. Emerging evidence demonstrates that combining brain radiotherapy (BRT) and immunotherapy may improve outcomes; however, the optimal strategy for combining these therapies remains undefined. This study was conducted to evaluate the efficacy and safety of concurrent BRT combined with tislelizumab and chemotherapy in patients with SCLC and brain metastases. Methods: Patients with treatment-naive or previously treated SCLC and brain metastases who were admitted to Zhejiang Cancer Hospital (Hangzhou, China) between September 2023 and November 2025 were enrolled. All patients received one cycle of chemotherapy combined with tislelizumab, followed by initiation of BRT within one week. Chemotherapy plus immunotherapy was subsequently continued, followed by maintenance immunotherapy until disease progression. The primary endpoint was intracranial objective response rate (iORR). Secondary endpoints included overall survival (OS), progression-free survival (PFS), disease control rate (DCR), and treatment-related adverse events (TRAEs). Results: Twenty-five patients were included. Among them, the iORR was 76.0%, and intracranial DCR was 100.0%. The systemic ORR and DCR were 56.0% and 80.0%, respectively. The median OS was 11.1 months [95% confidence interval (CI): 7.4-14.8], the median PFS was 5.6 months (95% CI: 3.1-8.1), and the median intracranial PFS was 7.6 months (95% CI: 5.7-9.5). TRAEs of any grade were identified in all patients, while grade ≥3 adverse events were found in 36.0% of patients. Hematological toxicity was most common (88.0%). Conclusions: Concurrent BRT combined with tislelizumab and chemotherapy demonstrated promising intracranial and systemic efficacy with manageable toxicity in SCLC patients with brain metastases and warrants further validation in larger prospective studies.
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