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Brief Title: Clinical Trial of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title: Clinical Trial on the Survival Advantage of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT03986528
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Kanglaite Injection for advanced non-small cell lung cancer(NSCLC).
Detailed Description: This study include a multicenter, randomized, controlled post-market clinical trial.The randomized clinical trial will enroll approximately 334 patients. Participants will be randomly divided into experimental (n=167) and control groups (n=167).Patients in the experimental group will receive Kanglaite Injection combination with first-line chemotherapy based on NCCN Guidelines (2019.V3). Patients in the control group will receive first-line chemotherapy based on NCCN Guidelines (2019.V3).The primary endpoint is PFS(progression free survival).The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Anhui Chest Hospital, Hefei, Anhui, China
Chongqing Cancer Hospital, Chongqing, Chongqing, China
Gansu Provincial Tumor Hospital, Lanzhou, Gansu, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guanzhou, Guangdong, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hunan Academy of Traditional Chinese Medicine Affiliated Hospital, Changsha, Hunan, China
Hunan Provincial Tumor Hospital, Changsha, Hunan, China
Jiangsu Province Hospital of Chinese Medicine, Nanjing, Jiangsu, China
XuZhou Central Hospital, Xuzhou, Jiangsu, China
The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, Shanghai, China
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine, Shanghai, Shanghai, China
Shanxi Provincial Cancer Hospital, Taiyuan, Shanxi, China
The Fourth Military Medical University Tangdu Hospital, Xian, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
The First Affiliated Hospital of Zhejiang Chinese Medicine University, Hangzhou, Zhejiang, China