Adebrelimab combined with apatinib and chemotherapy for neoadjuvant therapy and biomarker analysis in limited-stage small cell lung cancer: study protocol for a single-arm trial
- 1Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, Zhejiang, China
Abstract
Introduction: Small-cell lung cancer (SCLC) is an aggressive neuroendocrine malignancy with a poor overall prognosis. Surgery and concurrent chemoradiotherapy are currently recommended treatments for limited-stage SCLC (LS-SCLC), yet their efficacy remains limited. Recent advances have demonstrated the promising role of immunotherapy in LS-SCLC, reshaping the treatment paradigm. In parallel, neoadjuvant chemoimmunotherapy has become a standard of care for resectable non-small cell lung cancer. These provide a compelling rationale for exploring similar strategies in LS-SCLC to improve outcomes. We therefore conducted this study to evaluate the efficacy and safety of a novel neoadjuvant regimen incorporating adebrelimab, apatinib and chemotherapy in patients with LS-SCLC and to explore relevant biomarkers.
Methods and analysis: This is a single-arm, multicentre, prospective, exploratory phase II trial. A total of 38 patients with untreated, resectable LS-SCLC will receive four cycles of neoadjuvant therapy: adebrelimab (1200 mg, every 3 weeks (q3w)), apatinib (250 mg every other day (qod), 3 times/week, q3w for three cycles), and chemotherapy (etoposide plus carboplatin, q3w). Surgery is scheduled 4–8 weeks after neoadjuvant treatment (with a 4-week apatinib washout), followed by adjuvant adebrelimab plus apatinib with or without radiotherapy based on multidisciplinary assessment. The primary endpoint is 2-year event-free survival rate. Secondary endpoints include pathological complete response, major pathological response, objective response rate, overall survival, event-free survival and safety. Exploratory biomarker analyses using tumour tissue and serial blood samples will employ spatial single-cell sequencing, proteomics and circulating tumour DNA for minimal residual disease monitoring. We also use the tumour microenvironment using high-resolution spatial transcriptomics to explore the changing dynamics of tumour in situ trying to obtain the mechanistic explanation for potential non-responders.
Ethics and dissemination: This study was approved by the Medical Ethics Committee of Zhejiang Cancer Hospital, on 3 May 2024 (approval number IRB-2024-420 (IIT)). The version of this study protocol is V.8.0, dated 16 December 2025. The patients have been enrolled since June 2024. All participants will provide written informed consent. Results will be published in peer-reviewed journals and presented at scientific conferences.
Trial registration number: NCT06483282.
Related
- PD‐1 Inhibitor (Sintilimab) Combined With Chemotherapy as Neoadjuvant Therapy in Advanced Ovarian Cancer: A Case Report
- Splenic Enlargement During Neoadjuvant Chemotherapy for Gastric Cancer: Treatment-Related Phenomenon or Prognostic Biomarker?
- Analysis of Laryngoscopic Image Differences in Different Responses to Neoadjuvant Immunotherapy Combined With Chemotherapy in Locally Advanced Hypopharyngeal Carcinoma.
- Evaluation of the efficacy and safety of different cycles of neoadjuvant chemotherapy combined with immunotherapy in locally advanced esophageal squamous cell carcinoma: a multi-center, real-world study.
- Predictive Value of Combined Ultrasound Viscoelasticity Imaging, CEUS, AAPR, and PLR for Assessing Neoadjuvant Chemotherapy Efficacy in Breast Cancer
BibTeX
@article{jin2026adebrelimab,
title = {{Adebrelimab combined with apatinib and chemotherapy for neoadjuvant therapy and biomarker analysis in limited-stage small cell lung cancer: study protocol for a single-arm trial}},
author = {Ying Jin and Weishan Lu and Lishu Lou and Jian Zeng and Yun Fan and Da Chen},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2026-118036},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-118036},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Adebrelimab combined with apatinib and chemotherapy for neoadjuvant therapy and biomarker analysis in limited-stage small cell lung cancer: study protocol for a single-arm trial
AU - Ying Jin
AU - Weishan Lu
AU - Lishu Lou
AU - Jian Zeng
AU - Yun Fan
AU - Da Chen
PY - 2026
DA - 2026/10/21
JO - BMJ Open
DO - 10.1136/bmjopen-2026-118036
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-118036
AB - Introduction: Small-cell lung cancer (SCLC) is an aggressive neuroendocrine malignancy with a poor overall prognosis. Surgery and concurrent chemoradiotherapy are currently recommended treatments for limited-stage SCLC (LS-SCLC), yet their efficacy remains limited. Recent advances have demonstrated the promising role of immunotherapy in LS-SCLC, reshaping the treatment paradigm. In parallel, neoadjuvant chemoimmunotherapy has become a standard of care for resectable non-small cell lung cancer. These provide a compelling rationale for exploring similar strategies in LS-SCLC to improve outcomes. We therefore conducted this study to evaluate the efficacy and safety of a novel neoadjuvant regimen incorporating adebrelimab, apatinib and chemotherapy in patients with LS-SCLC and to explore relevant biomarkers. Methods and analysis: This is a single-arm, multicentre, prospective, exploratory phase II trial. A total of 38 patients with untreated, resectable LS-SCLC will receive four cycles of neoadjuvant therapy: adebrelimab (1200 mg, every 3 weeks (q3w)), apatinib (250 mg every other day (qod), 3 times/week, q3w for three cycles), and chemotherapy (etoposide plus carboplatin, q3w). Surgery is scheduled 4–8 weeks after neoadjuvant treatment (with a 4-week apatinib washout), followed by adjuvant adebrelimab plus apatinib with or without radiotherapy based on multidisciplinary assessment. The primary endpoint is 2-year event-free survival rate. Secondary endpoints include pathological complete response, major pathological response, objective response rate, overall survival, event-free survival and safety. Exploratory biomarker analyses using tumour tissue and serial blood samples will employ spatial single-cell sequencing, proteomics and circulating tumour DNA for minimal residual disease monitoring. We also use the tumour microenvironment using high-resolution spatial transcriptomics to explore the changing dynamics of tumour in situ trying to obtain the mechanistic explanation for potential non-responders. Ethics and dissemination: This study was approved by the Medical Ethics Committee of Zhejiang Cancer Hospital, on 3 May 2024 (approval number IRB-2024-420 (IIT)). The version of this study protocol is V.8.0, dated 16 December 2025. The patients have been enrolled since June 2024. All participants will provide written informed consent. Results will be published in peer-reviewed journals and presented at scientific conferences. Trial registration number: NCT06483282.
SN - 2044-6055
SN - 2044-6055
ER -