Lung Cancer Clinical Trial
A Study to Evaluate the Efficacy and Safety of HLX10 in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer
Summary
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10 + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.
Full Description
Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.
Arm A (HLX10 arm): HLX10 + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).
Eligibility Criteria
Inclusion Criteria:
Male or female, aged ≥18 years when signing the ICF.
Histologically diagnosed with SCLC.
Diagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.
Major organs are functioning well.
Exclusion Criteria:
Histologically or cytologically confirmed mixed SCLC.
Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.
Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.
Patients with other active malignancies within 5 years or at the same time.
Subjects with known history of severe allergy to any monoclonal antibody.
Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 70 Locations for this study
Anaheim California, 92805, United States More Info
Contact
Pasadena California, 91101, United States More Info
Contact
Redlands California, 92373, United States More Info
Contact
Massillon Ohio, 44646, United States More Info
Contact
Tyler Texas, 75701, United States More Info
Contact
Tacoma Washington, 98405, United States More Info
Contact
Klagenfurt am Wörthersee , 9020, Austria More Info
Contact
Wien , 1210, Austria More Info
Contact
Bengbu Anhui, 23309, China
Hefei Anhui, 23003, China
Beijing Beijing, 10002, China
Beijing Beijing, 10003, China
Beijing Beijing, 10014, China
Chongqing Chongqing, 40001, China
Chongqing Chongqing, 40003, China
Fuzhou Fujian, 35000, China
Fuzhou Fujian, 35001, China
Guangzhou Guangdong, 51000, China
Guangzhou Guangdong, 51003, China
Shenzhen Guangdong, 51803, China
Guilin Guangxi, 54110, China
Nanning Guangxi, 53002, China
Guangzhou Guangzhou, 51009, China
Baoding Hebei, 07100, China
Cangzhou Hebei, 06101, China
Tangshan Hebei, 06300, China
Harbin Heilongjiang, 15000, China
Jiamusi Heilongjiang, 15400, China
Luoyang Henan, 47100, China
Xinxiang Henan, 45310, China
Zhengzhou Henan, 45000, China
Zhengzhou Henan, 45005, China
Shiyan Hubei, 44200, China
Wuhan Hubei, 43003, China
Wuhan Hubei, 43007, China
Wuhan Hubei, 43007, China
Changde Hunan, 41500, China
Changsha Hunan, 41000, China
Changsha Hunan, 41001, China
Changsha Hunan, 41001, China
Hohhot Inner Mongolia, 01000, China
Nanjing Jiangsu, 21002, China
Xuzhou Jiangsu, 22100, China
Yangzhou Jiangsu, 21000, China
Ganzhou Jiangxi, 34100, China
Ganzhou Jiangxi, 34100, China
Nanchang Jiangxi, 33000, China
Changchun Jilin, 13000, China
Changchun Jilin, 13002, China
Shenyang Liao Ning, 11004, China
Shenyang Liao Ning, 11004, China
Jinan Shandong, 25001, China
Jinan Shandong, 25011, China
Linyi Shandong, 27600, China
Qingdao Shandong, 26603, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20003, China
Wenzhou Shanghai, 20003, China
Baoji Shanxi, 72100, China
TaiYuan Shanxi, 03001, China
Xi'an Shanxi, 71006, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 30005, China
Tianjin Tianjin, 30005, China
Sichuan Yibin, 64400, China
Kunming Yunnan, 65011, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Taizhou Zhejiang, 31700, China
Wenzhou Zhejiang, 32500, China
Ostrava-Vítkovice , 703 0, Czechia More Info
Contact
How clear is this clinincal trial information?