Clinical Trial of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- NSCLC
- Interventions
- Drug: ChemotherapyDrug: Kanglaite Injection+Chemotherapy
- Registration Number
- NCT03986528
- Lead Sponsor
- Jie Li
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 334
- A Histological or cytological confirmed diagnosis of Stage III-IV NSCLC, with no history of anticancer treatment including chemotherapy;
- Male or female aged 18-75years;
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2;
- Life expectancy of at least 3 months;
- At least one radiographically measurable lesion per RECIST 1.1;
- Willing to join the clinic trail and sign informed consent;
- Able to comply with scheduled visits and treatments.
- Presence of cerebral metastases;
- Confirmed positive for expression of expression of epidermal growth factor receptor (EGFR), activin receptor-like kinase (ALK), c-ros oncogene 1 (ROS1) mutation, or programmed death-ligand 1 (PD-L1)(tumor proportion score [TPS≥ 50%] in a genetic test;
- Participants with malignant pleural effusion underwent intrapleural injection chemotherapy;
- Current undergoing or preparing for treatment with target therapy;
- Current undergoing or preparing for radiotherapy to the thorax;
- Current undergoing or preparing treatment with tumor immunotherapy;
- Currently undergoing lipid-decreasing treament;
- Pregnant or breastfeeding woman;
- Fertile patients who are unwilling or unable to take effective contraceptive measures during the research period until 6 months after the study end later;
- A history of mental disorders；
- Severe and uncontrolled organic lesion or infection, including but not limited to cardiopulmonary failure and renal failure，which lead to poor tolerance of chemotherapy;
- Participated in other clinical trials of small molecule research drugs within 28 days prior to enrollment, or participated in other clinical trials of large molecule research drugs within 3 months before enrollment;
- Known allergy or intolerance to study medications;
- Considered to be otherwise unsuitable for the clinical study by researchers.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy Chemotherapy first-line chemotherapy. Kanglaite Injection + Chemotherapy Kanglaite Injection+Chemotherapy Participants receive Kanglaite Injection PLUS first-line chemotherapy.
- Primary Outcome Measures
Name Time Method Progression Free Survival(PFS) Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first. Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- Secondary Outcome Measures
Name Time Method One-Year Survival Rate Randomization until One year. One-year survival rate refers to the proportion of patients with a survival period of more than one year starting from randomized enrollment.
Blood lipid every 41-56 days(2 cycles ) until disease progression, death, or assessed up to 12 months after randomized enrollment. total cholesterol, triacylglycerides, high density cholesterol, low density cholesterol.
Percentage of Participants With Adverse Events Baseline until disease progression,death, or assessed up to 12 months after randomized enrollment. Percentage of Participants With Adverse Events in different arms.
Objective Response Rate (ORR) Every two cycles (each cycle is 21-28 days) until disease progression, death, or 12 months after randomized enrollment, whichever occurs first. ORR is defined as the percentage of participants who had a Complete Response (CR:Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by RECIST 1.1.
Quality of life of the patient before and after each cycle of treatment, assessed up to 12 months after randomized enrollment This will be measured with validated questionnaires (EORTC-QLQ C30) and Lung Cancer Symptom Scale(LCSS).
Living ability of the patient before and after each cycle of treatment, assessed up to 12 months after randomized enrollment This will be measured with validated questionnaires(ECOG) and Karnofsky performance status (KPS).
Trial Locations
- Locations (17)
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
Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
🇨🇳Changsha, Hunan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, 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
The Fourth Military Medical University Tangdu Hospital
🇨🇳Xian, Shanxi, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Zhejiang Chinese Medicine University
🇨🇳Hangzhou, Zhejiang, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China