Holistic Integrative Oncology · Published 2026-07-28 · DOI 10.1007/s44178-026-00281-w
Haitao Tao, Jianhua Chen, Dongqing Lv, Jinliang Wang, Junxun Ma, Tienan Yi, Shikai Wu, Xiangdong Zhou, Xingxing Zhang, Dongmei Chen, Songhua Fan, Chen Zhong, Chunyu Guan, Michael Shi, Weiguo Su, Yi Hu
Abstract Purpose Patients with extensive-stage small cell lung cancer (ES-SCLC) have poor prognosis. This phase 2 study evaluated the efficacy and safety of surufatinib plus programmed death-1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors as maintenance therapy in patients with ES-SCLC without disease progression after first-line chemoimmunotherapy. Methods Patients with ES-SCLC and with non-progressive disease after 4–6 cycles of platinum-based chemotherapy plus PD-1/PD-L1 inhibitors received oral surufatinib 250 mg once daily plus PD-1/PD-L1 therapy. The primary endpoint was progression-free survival (PFS) assessed by investigators. Results A total of 21 patients (71.4% aged under 65 years; 61.9% with 5–6 induction cycles) were enrolled between 19 September 2022 and 30 June 2023 and received ≥ 1 study treatment. The median PFS was 4.0 months (95% CI: 1.9–6.4) from maintenance therapy initiation and 8.8 months (95% CI: 6.5–13.4) from induction therapy initiation. From initiation of maintenance treatment, median overall survival (OS) was not reached after 17.1 months of follow-up and the 18-month OS was 57.1% (95% CI: 33.8–74.9). Among 13 patients with measurable lesions at baseline, the objective response rate was 23.1% (95% CI: 5.0–53.8), and disease control rate was 53.8% (95% CI: 25.1–80.8). Treatment-related adverse events (TRAEs) occurred in 19 patients (90.5%), with grade ≥ 3 TRAEs reported in six patients (28.6%). Two patients (9.5%) discontinued due to TRAEs; no treatment-related deaths occurred. Conclusions Surufatinib combined with PD-1/PD-L1 inhibitors as first-line maintenance therapy showed encouraging PFS and a tolerable safety profile in patients with ES-SCLC who received chemotherapy combined with PD-1/PD-L1 inhibitors as first-line induction therapy. Trial registration ClinicalTrials.gov, NCT05509699. Registered 16 August 2022, https//clinicaltrials.gov/study/NCT05509699.
Abstract from DOAJ. Public domain (CC0 1.0).
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Tao, H., Chen, J., Lv, D., et al. (2026). Efficacy and safety of surufatinib plus PD-1/PD-L1 inhibitors as first-line maintenance therapy in extensive-stage small cell lung cancer. Holistic Integrative Oncology. https://doi.org/10.1007/s44178-026-00281-w