A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer
Abstract This is a randomized, double-blind, placebo-controlled phase 3 clinical trial (ClinicalTrials.gov, NCT04878016) conducted in 54 hospitals in China. Adults who were histologically diagnosed and never treated for extensive-stage small cell lung cancer (ES-SCLC) were enrolled. Eligible Patient...
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Nature Publishing Group
2025-01-01
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| Series: | Signal Transduction and Targeted Therapy |
| Online Access: | https://doi.org/10.1038/s41392-024-02115-5 |
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| author | Zhiwei Chen Jianhua Chen Dingzhi Huang Wei Zhang Lin Wu Tienan Yi Qiming Wang Liang Han Liping Tan Yinyin Li Zhihong Zhang Na Li Jie li Tongmei Zhang Ying Hu Hongmei Sun Youhua Wu Zhiyong He Runxiang Yang Peng Cheng Xingya Li Jianhua Shi Guohua Yu Daiyuan Ma Benjamin Xiaoyi Li Xiangrong Dai Michael Wong Yujie Li Xiaohui Yu Shun Lu for the Socazolimab Study Group |
| author_facet | Zhiwei Chen Jianhua Chen Dingzhi Huang Wei Zhang Lin Wu Tienan Yi Qiming Wang Liang Han Liping Tan Yinyin Li Zhihong Zhang Na Li Jie li Tongmei Zhang Ying Hu Hongmei Sun Youhua Wu Zhiyong He Runxiang Yang Peng Cheng Xingya Li Jianhua Shi Guohua Yu Daiyuan Ma Benjamin Xiaoyi Li Xiangrong Dai Michael Wong Yujie Li Xiaohui Yu Shun Lu for the Socazolimab Study Group |
| author_sort | Zhiwei Chen |
| collection | DOAJ |
| description | Abstract This is a randomized, double-blind, placebo-controlled phase 3 clinical trial (ClinicalTrials.gov, NCT04878016) conducted in 54 hospitals in China. Adults who were histologically diagnosed and never treated for extensive-stage small cell lung cancer (ES-SCLC) were enrolled. Eligible Patients were randomly assigned (1:1) to receive four cycles (21 days as one cycle) of intravenous carboplatin (area under the curve of 5 mg/mL per min, day 1 of each cycle) and etoposide (100 mg/m² of body-surface area, on days 1–3 of each cycle) with either socazolimab (5 mg/kg, day 1 of each cycle) or matching placebo, following maintenance therapy with socazolimab or placebo. From July 15, 2021, to May 12, 2022, 498 eligible patients were randomly assigned to receive socazolimab (250 patients) or placebo (248 patients) combined with chemotherapy. As of October 13, 2023, patients treated with socazolimab presented significant overall survival (OS) benefit (13.90 months) compared with the placebo plus EC group (11.58 months) (hazard ratio for death, 0.799; 95% CI, 0.652–0.979; p = 0.0158). The median progression free survival (PFS) was 5.55 months in the socazolimab plus EC group, prolonging disease progression or death by nearly 1.2 months (5.55 months vs 4.37 months, hazard ratio for progression or death, 0.569; 95% CI, 0.457–0.708; p < 0.0001). 200 (80.3%) patients in the socazolimab plus EC group experienced ≥ grade 3 treatment-related adverse events and 187 (75.7%) patients occurred in the placebo plus EC group. Socazolimab combined with standard EC regimen chemotherapy for first-line treatment of ES-SCLC significantly prolonged overall survival and did not increase the safety risk of treatment. |
| format | Article |
| id | doaj-art-87b2805e12384c2ab516fdfc09fb0d8e |
| institution | Kabale University |
| issn | 2059-3635 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Nature Publishing Group |
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| series | Signal Transduction and Targeted Therapy |
| spelling | doaj-art-87b2805e12384c2ab516fdfc09fb0d8e2025-01-19T12:40:24ZengNature Publishing GroupSignal Transduction and Targeted Therapy2059-36352025-01-011011810.1038/s41392-024-02115-5A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancerZhiwei Chen0Jianhua Chen1Dingzhi Huang2Wei Zhang3Lin Wu4Tienan Yi5Qiming Wang6Liang Han7Liping Tan8Yinyin Li9Zhihong Zhang10Na Li11Jie li12Tongmei Zhang13Ying Hu14Hongmei Sun15Youhua Wu16Zhiyong He17Runxiang Yang18Peng Cheng19Xingya Li20Jianhua Shi21Guohua Yu22Daiyuan Ma23Benjamin Xiaoyi Li24Xiangrong Dai25Michael Wong26Yujie Li27Xiaohui Yu28Shun Lu29for the Socazolimab Study GroupDepartment of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Medical Oncology, Hunan Cancer HospitalDepartment of Medical Oncology, Tianjin Tumor HospitalDepartment of Respiratory Medicine, First Affiliated Hospital of Nanchang UniversityDepartment of Medical Oncology, Hunan Cancer HospitalDepartment of Medical Oncology, Xiangyang Central HospitalDepartment of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer HospitalDepartment of Medical Oncology, Xuzhou Central HospitalDepartment of Medical Oncology, Guangxi Medical University cancer HospitalDepartment of Medical Oncology, Shenyang Tenth People’s HospitalDepartment of Respiratory Medicine, Anhui Provincial Cancer HospitalDepartment of Medical Oncology, Suining Central HospitalDepartment of Respiratory Medicine, First Affiliated Hospital of Gannan Medical UniversityDepartment of Medical Oncology, Beijing Chest Hospital Affiliated to Capital Medical UniversityDepartment of Medical Oncology, Beijing Chest Hospital Affiliated to Capital Medical UniversityDepartment of Medical Oncology, Jiamusi Cancer HospitalDepartment of Medical Oncology, First Affiliated Hospital of University of South ChinaDepartment of Medical Oncology, Fujian Cancer HospitalDepartment of Medical Oncology, Yunnan Cancer HospitalDepartment of Medical Oncology, First Affiliated Hospital of Nanyang Medical CollegeDepartment of Medical Oncology, First Affiliated Hospital of Zhengzhou UniversityDepartment of Medical Oncology, Linyi Cancer HospitalDepartment of Medical Oncology, Weifang People’s HospitalDepartment of Medical Oncology, Affiliated Hospital of North Sichuan Medical CollegeZhaoke (Guangzhou) Oncology PharmaceuticalsZhaoke (Guangzhou) Oncology PharmaceuticalsZhaoke (Guangzhou) Oncology PharmaceuticalsZhaoke (Guangzhou) Oncology PharmaceuticalsZhaoke (Guangzhou) Oncology PharmaceuticalsDepartment of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of MedicineAbstract This is a randomized, double-blind, placebo-controlled phase 3 clinical trial (ClinicalTrials.gov, NCT04878016) conducted in 54 hospitals in China. Adults who were histologically diagnosed and never treated for extensive-stage small cell lung cancer (ES-SCLC) were enrolled. Eligible Patients were randomly assigned (1:1) to receive four cycles (21 days as one cycle) of intravenous carboplatin (area under the curve of 5 mg/mL per min, day 1 of each cycle) and etoposide (100 mg/m² of body-surface area, on days 1–3 of each cycle) with either socazolimab (5 mg/kg, day 1 of each cycle) or matching placebo, following maintenance therapy with socazolimab or placebo. From July 15, 2021, to May 12, 2022, 498 eligible patients were randomly assigned to receive socazolimab (250 patients) or placebo (248 patients) combined with chemotherapy. As of October 13, 2023, patients treated with socazolimab presented significant overall survival (OS) benefit (13.90 months) compared with the placebo plus EC group (11.58 months) (hazard ratio for death, 0.799; 95% CI, 0.652–0.979; p = 0.0158). The median progression free survival (PFS) was 5.55 months in the socazolimab plus EC group, prolonging disease progression or death by nearly 1.2 months (5.55 months vs 4.37 months, hazard ratio for progression or death, 0.569; 95% CI, 0.457–0.708; p < 0.0001). 200 (80.3%) patients in the socazolimab plus EC group experienced ≥ grade 3 treatment-related adverse events and 187 (75.7%) patients occurred in the placebo plus EC group. Socazolimab combined with standard EC regimen chemotherapy for first-line treatment of ES-SCLC significantly prolonged overall survival and did not increase the safety risk of treatment.https://doi.org/10.1038/s41392-024-02115-5 |
| spellingShingle | Zhiwei Chen Jianhua Chen Dingzhi Huang Wei Zhang Lin Wu Tienan Yi Qiming Wang Liang Han Liping Tan Yinyin Li Zhihong Zhang Na Li Jie li Tongmei Zhang Ying Hu Hongmei Sun Youhua Wu Zhiyong He Runxiang Yang Peng Cheng Xingya Li Jianhua Shi Guohua Yu Daiyuan Ma Benjamin Xiaoyi Li Xiangrong Dai Michael Wong Yujie Li Xiaohui Yu Shun Lu for the Socazolimab Study Group A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer Signal Transduction and Targeted Therapy |
| title | A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer |
| title_full | A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer |
| title_fullStr | A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer |
| title_full_unstemmed | A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer |
| title_short | A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer |
| title_sort | multicenter randomized double blind placebo controlled phase 3 study of socazolimab or placebo combined with carboplatin and etoposide in the first line treatment of extensive stage small cell lung cancer |
| url | https://doi.org/10.1038/s41392-024-02115-5 |
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