首页|Sintilimab combined with anlotinib and chemotherapy as second-line or later therapy in extensive-stage small cell lung cancer:a phase Ⅱ clinical trial

Sintilimab combined with anlotinib and chemotherapy as second-line or later therapy in extensive-stage small cell lung cancer:a phase Ⅱ clinical trial

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Treatment options for patients with relapsed extensive-stage small cell lung cancer(ES-SCLC)remain scarce.This study aims to evaluate the efficacy and safety of combining anlotinib and sintilimab plus chemotherapy as a second line or later therapy for ES-SCLC patients.This is a phase Ⅱ clinical trial(ChiCTR2100049390)conducting at Shandong Cancer Hospital.Patients with ES-SCLC and received at least one prior systemic treatment were enrolled.The trial design involved a combination therapy(sintilimab,anlotinib,and nab-paclitaxel)administered over six 21-day cycles,followed by maintenance sintilimab therapy.The primary endpoint was objective response rate(ORR).Circulating tumor DNA sequencing was employed for exploratory analysis.From July 2021 to April 2023,25 eligible patients were enrolled.The confirmed ORR was 60％(95％CI:38.7-78.9％)and the DCR was 76％(95％CI:54.9-90.6％).The mPFS was 6.0 months(95％CI:5.4-9.7),and the 6-month PFS rate was 49.2％.The mOS was 13.4 months(95％CI:11.8-NR),with a 12-month survival rate of 62.2％.Treatment-related adverse events(TRAEs)of any grade occurred in 80％of patients,with the most common being fatigue(40％)and nausea(32％).TRAEs of Grade 3 or higher were reported in 12％of patients.ctDNA analysis indicated that low on-treatment blood tumor mutation burden was associated with longer PFS and OS and a potential role of KMT2D mutation in treatment resistance.This combination therapy shows promising efficacy and a manageable safety profile as a second-line or later treatment for ES-SCLC,with genomic insights providing potential biomarkers for treatment response.

Xiao Han、Jun Guo、Lingyu Li、Yong Huang、Xue Meng、Linlin Wang、Hui Zhu、Xiangjiao Meng、Qian Shao、Xing Li、Yan Zhang、Jin Wang、Yanhua Chen、Yingjie Zhang、Yiru Chen、Changbin Zhu、Zhehai Wang

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Department of Medical Oncology,Shandong Cancer Hospital and Institute,Shandong First Medical University and Shandong Academy of Medical Sciences,Jinan,Shandong,China

Department of Medical Oncology,Shanghe County People's Hospital,Jinan,Shandong,China

Department of Imageology,Shandong Cancer Hospital and Institute,Shandong First Medical University and Shandong Academy of Medical Sciences,Jinan,China

Department of Radiation Oncology,Shandong Cancer Hospital and Institute,Shandong First Medical University and Shandong Academy of Medical Science,Jinan,Shandong,China

School of Public Health,Shandong First Medical University & Shandong Academy of Medical Sciences,Jinan,China

Department of Translational Medicine,Amoy Diagnostics,Xiamen,Fujian,China

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Natural Science Foundation of Shandong ProvinceShandong medical and health science and technology development plan project

ZR2023LSW024202103100568

2024

10.1038/s41392-024-01957-3

信号转导与靶向治疗(英文)

信号转导与靶向治疗(英文)

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年,卷(期)：2024.9(10)