Trial reportCancer immunology, immunotherapy : CII2025
Efficacy and safety of surufatinib plus toripalimab in treatment-naive, PD-L1-positive, advanced or metastatic non-small-cell lung cancer and previously treated small-cell lung cancer: an open-label, single-arm, multicenter, multi-cohort phase II trial.
Trial report in Cancer immunology, immunotherapy : CII, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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The trial behind it
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Who cites it
5 citing papers in PubMed.
- Surufatinib plus toripalimab for patients with advanced solid tumors and disease progression after prior immunotherapy: an open-label multi-cohort phase 2 trial.Cancer immunology, immunotherapy : CII · 2026Trial
- Pancreatic ductal adenocarcinoma: integrating molecular insights for targeted interventions.Signal transduction and targeted therapy · 2026Review
- Review
- The Five-Decade Journey of Small Cell Lung Cancer.Cancer communications (London, England) · 2026Review
- The prognostic impact of surufatinib for the treatment of advanced pancreatic ductal adenocarcinoma: a single center real-world retrospective study.Frontiers in oncology · 2025Article
Corrections and comments
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCombining the programmed death-1 inhibitor toripalimab and the angio-immuno kinase inhibitor surufatinib showed preliminary antitumor activity in patients with advanced solid tumors in a phase I study. Here, we report the efficacy and safety of this combination regimen in treatment-naive advanced or metastatic non-small-cell lung cancer (NSCLC) patients with a programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) of 1% or greater (PD-L1-positive) and patients with previously treated small-cell lung cancer (SCLC).
methodsThis open-label, single-arm phase II study included patients with treatment-naive advanced or metastatic PD-L1-positive NSCLC or previously treated SCLC in China. Patients received surufatinib (250 mg orally, once daily) plus toripalimab (240 mg intravenously, once every 3 weeks). Primary endpoint was investigator-assessed objective response rate (ORR) per RECIST v1.1. Secondary endpoints included duration of response (DoR), disease control rate, progression-free survival (PFS), overall survival (OS), and safety.
resultsForty-three patients were treated (NSCLC cohort, n = 23; SCLC cohort, n = 20). ORRs (95% CIs) were 57.1% (34.0-78.2) in the NSCLC cohort and 15.8% (3.4-39.6) in the SCLC cohort. Median duration of response was not reached (NR) in both cohorts. Median PFS was 9.6 (5.5-NR) and 3.0 months (2.8-4.1), respectively, and median OS was 24.3 (10.8-NR) and 11.0 months (5.0-15.7), respectively. Grade ≥ 3 treatment-related adverse events were reported in 24 patients (55.8%) overall.
conclusionSurufatinib plus toripalimab showed encouraging antitumor activity and a tolerable safety profile in patients with treatment-naive advanced or metastatic PD-L1-positive NSCLC and previously treated SCLC.
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