First-line camrelizumab plus chemotherapy followed by camrelizumab-apatinib maintenance for ES-SCLC: a single-arm phase II study.

Authors

Minghui Zhang, Mingyuan Guo, Lijun Li, Changfan Qu, Jinglei Liu, Haihong Pu, Xin Li, Yinghong Li, Li Guo, Zhao Jin, Chen Yang, Yu Zhang, Jian Shen, Yue Gao, Qingwei Meng, Yanbin Zhao

Published in

Lung cancer (Amsterdam, Netherlands). Pages 109623. Sep 11, 2026. Epub Sep 11, 2026.

Abstract

Immune-antiangiogenic combinations have shown promising signals of activity in ES-SCLC, but the optimal timing of anti-angiogenic therapy and biomarkers associated with benefit remain undefined. This study evaluated the efficacy and safety of combining apatinib with camrelizumab during maintenance and explored immune-molecular biomarkers of benefit.
In this single-arm phase II trial, apatinib plus camrelizumab as maintenance therapy following induction therapy with camrelizumab plus platinum-etoposide chemotherapy was administered to treatment-naïve ES-SCLC patients (ACES). The primary endpoint was 6-month progression-free survival (PFS) rate; secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), PFS, and safety. Multiplex immunofluorescence (mIF) and RNA sequencing were performed as exploratory immune-molecular analyses.
Between March 2021 and July 2024, 41 patients were enrolled. At a median follow-up of 31.0 months, the 6-month PFS rate was 71.1% (95% CI: 53.9-82.9), with median PFS and OS of 8.7 months (95% CI: 6.9-10.6) and 17.2 months (95% CI: 14.5-19.9), respectively. ORR was 82.9% and DCR was 92.7%. Grade ≥ 3 treatment-related adverse events occurred in 22.0% of patients, with no treatment-related deaths. MIF revealed that durable clinical benefit was associated with a "high-CD8⁺/low-M2" immune phenotype. Transcriptomic profiling suggested an exploratory 9-gene expression pattern associated with progression-free survival.
Camrelizumab plus chemotherapy followed by camrelizumab-apatinib maintenance showed preliminary antitumor activity with manageable safety in patients with ES-SCLC. Exploratory immune-molecular profiling suggested a putative "high-CD8⁺/low-M2" immune phenotype and a 9-gene expression pattern associated with clinical benefit.

PMID:
42767923
Bibliographic data and abstract were imported from PubMed on 22 Sep 2026.

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