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Spots Global Cancer Trial Database for Clinical Trial of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)

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Trial Identification

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

Conditions

NSCLC

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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