ArticleEClinicalMedicine2025
Efficacy and safety of tislelizumab plus anlotinib and irinotecan as second-line treatment for extensive-stage small cell lung cancer: a single-arm, open-label, phase II trial.
Article in EClinicalMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05027100 (One Arm, Exploratory Study of Tislelizumab Combined With Anlotinib and 2-cycle Irinotecan Monotherapy as Second Treatment of Small Cell Lung Cancer), which is not on this map. Cited by 1 paper.
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One Arm, Exploratory Study of Tislelizumab Combined With Anlotinib and 2-cycle Irinotecan Monotherapy as Second Treatment of Small Cell Lung Cancer
Who cites it
1 citing paper in PubMed.
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Extensive-stage small cell lung cancer (ES-SCLC) often recurs after platinum-based chemotherapy, with limited second-line options. This phase II trial evaluated the efficacy and safety of tislelizumab combined with anlotinib and irinotecan as second-line therapy for ES-SCLC. Methods: In this single-arm, open-label phase II trial (NCT05027100) conducted in China, patients with ES-SCLC who progressed after first-line platinum-based chemotherapy were enrolled. Patients received tislelizumab (200 mg intravenously every 3 weeks), anlotinib (10 mg orally, days 1-14), and irinotecan (100 mg/m Findings: Between September 2021 and March 2024, 32 patients were enrolled. At a median follow-up of 9.6 months (IQR: 7.4-21.9), ORR was 50% (16/32, 95% CI: 32%-68%), median PFS was 7.1 months (95% CI: 3.1-9.9), and median OS was 7.5 months (95% CI: 5.3-11.0). Grade ≥3 treatment-related adverse events occurred in 25% (8/32) of patients, with two grade ≥3 immune-related events. Interpretation: Tislelizumab, anlotinib, and irinotecan demonstrated promising efficacy and manageable toxicity as second-line therapy for ES-SCLC post-platinum-based chemotherapy or immune checkpoint inhibitors. Funding: This work was supported by the Guangzhou Key Laboratory of Acupuncture and Medicine Research, Beijing Health Alliance Charitable Foundation, the National Key Research and Development Program of China (2023YFC3503303), and Major Scientific and Technological Projects of Chinese Medicine in Guangzhou area (2025ZD007).
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