Rationale and Design of a Phase II Trial of Combined Serplulimab and Chemotherapy in Patients with Histologically Transformed Small Cell Lung Cancer: a Prospective, Single-arm and Multicentre Study

Huang, J.1; Zhang, X. -H.1; Cai, Y.2; Yang, D.3; Shi, J.4; Xing, P.5; Xu, T.6; Wu, L.7; Su, W.8; Xu, R.9; Wei, T.10; Chen, H. -J.1; Yang, J. -J.1

2024

10.1016/j.clon.2023.11.030

CLINICAL ONCOLOGY   影响因子和分区

0936-6555

1433-2981

Aims: Transformed small cell lung cancer (T-SCLC) is a highly aggressive clinical disease with a notably poor prognosis. It most often arises from epidermal growth factor receptor (EGFR)-mutant non -small cell lung cancer (NSCLC) following treatment. To date, no standard treatment has been established for T-SCLC. Platinum-etoposide was the most commonly used regimen, but progression -free survival remains unsatisfactory. Therefore, there is an urgent unmet need to develop novel and effective strategies for this population. Our study, a multicentre, open -label, single -arm phase II clinical trial (NCT05957510), aims to evaluate the efficacy and safety of serplulimab plus chemotherapy in untreated T-SCLC patients after histological transformation. Materials and methods: In total, 36 eligible participants experiencing SCLC transformation from EGFR-mutant NSCLC will be enrolled to receive combination therapy of serplulimab, etoposide and carboplatin for four to six cycles, followed by maintenance therapy with serplulimab for up to 2 years. The primary endpoint is progression -free survival; secondary endpoints include objective response rate, overall survival and safety. Results: Enrolment started in July 2023 and is ongoing, with an estimated completion date of December 2025. Conclusions: This study aims to provide valuable insights into the efficacy and safety of combining serplulimab with chemotherapy for treating patients with TSCLC originating from EGFR-mutant NSCLC. (c) 2023 Published by Elsevier Ltd on behalf of The Royal College of Radiologists.

Biomarker platinum-etoposide serplulimab transformed SCLC (T-SCLC)

SCI

英语

其他

High-level Hospital Construction Project[DFJH201917] ; Guangdong Provincial Key Lab of Translational Medicine in Lung Cancer[2017B030314120] ; National Natural Science Foundation of China["81972164","82003273"] ; High-level Hospital Construction Project[DFJH201809] ; Natural Science Foundation of Guangdong Province[2019A1515010931]

Oncology

Oncology

WOS:001156185700001

ELSEVIER SCIENCE LONDON

CLINICAL MEDICINE

Web of Science

1.Southern Med Univ, Guangdong Prov Peoples Hosp, Guangdong Lung Canc Inst, Guangdong Acad Med Sci, Guangzhou, Peoples R China
2.Guangdong Nongken Cent Hosp, Med Oncol Dept 5, Zhanjiang, Peoples R China
3.Fujian Med Univ, Affiliated Hosp 2, Quanzhou, Peoples R China
4.Hebei Med Univ, Hosp 4, Shijiazhuang, Peoples R China
5.Chinese Acad Med Sci & Peking Union Med Coll, Natl Canc Ctr, Natl Clin Res Ctr Canc, Canc Hosp, Beijing, Peoples R China
6.Qingdao Univ, Affiliated Hosp, Qingdao, Peoples R China
7.Gannan Med Univ, Affiliated Hosp 1, Ganzhou, Peoples R China
8.Guangdong Med Univ, Dept Pulm Oncol, Affiliated Hosp, Zhanjiang, Peoples R China
9.Southern Univ Sci & Technol, Affiliated Hosp Southern Univ Sci & Technol 1, Shenzhen Peoples Hosp, Clin Med Coll 2,Affiliated Hosp 1,Dept Oncol, Shenzhen, Peoples R China
10.Southern Med Univ, Zhujiang Hosp, Dept Oncol, Guangzhou, Peoples R China

Huang, J.,Zhang, X. -H.,Cai, Y.,et al. Rationale and Design of a Phase II Trial of Combined Serplulimab and Chemotherapy in Patients with Histologically Transformed Small Cell Lung Cancer: a Prospective, Single-arm and Multicentre Study[J]. CLINICAL ONCOLOGY,2024,36(1).

Huang, J..,Zhang, X. -H..,Cai, Y..,Yang, D..,Shi, J..,...&Yang, J. -J..(2024).Rationale and Design of a Phase II Trial of Combined Serplulimab and Chemotherapy in Patients with Histologically Transformed Small Cell Lung Cancer: a Prospective, Single-arm and Multicentre Study.CLINICAL ONCOLOGY,36(1).

Huang, J.,et al."Rationale and Design of a Phase II Trial of Combined Serplulimab and Chemotherapy in Patients with Histologically Transformed Small Cell Lung Cancer: a Prospective, Single-arm and Multicentre Study".CLINICAL ONCOLOGY 36.1(2024).