The purpose of this study is to evaluate the efficacy and safety of Kanglaite Injection for advanced non-small cell lung cancer(NSCLC).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
334
Patients will receive investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle) according pathologic types. Patients with CR, PR, or SD after 4-6 cycles of platinum-based double chemotherapy regimens will receive non-platinum single-agent chemotherapy. The patients will also receive Kanglaite injection 200ml by IV infusion per day continuously for 14 days, commencing on the first day of chemotherapy.
Patients will receive investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle) according pathologic types. Patients with CR, PR, or SD after 4-6 cycles of platinum-based double chemotherapy regimens will receive non-platinum single-agent chemotherapy.
Anhui Chest Hospital
Hefei, Anhui, China
Progression Free Survival(PFS)
Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
Objective Response Rate (ORR)
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.
Time frame: Every two cycles (each cycle is 21-28 days) until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
One-Year Survival Rate
One-year survival rate refers to the proportion of patients with a survival period of more than one year starting from randomized enrollment.
Time frame: Randomization until One year.
Quality of life of the patient
This will be measured with validated questionnaires (EORTC-QLQ C30) and Lung Cancer Symptom Scale(LCSS).
Time frame: before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
Living ability of the patient
This will be measured with validated questionnaires(ECOG) and Karnofsky performance status (KPS).
Time frame: before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
Blood lipid
total cholesterol, triacylglycerides, high density cholesterol, low density cholesterol.
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Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGGansu Provincial Tumor Hospital
Lanzhou, Gansu, China
RECRUITINGThe First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guanzhou, Guangdong, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGHunan Academy of Traditional Chinese Medicine Affiliated Hospital
Changsha, Hunan, China
RECRUITINGHunan Provincial Tumor Hospital
Changsha, Hunan, China
RECRUITINGJiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, China
RECRUITINGXuZhou Central Hospital
Xuzhou, Jiangsu, China
RECRUITINGThe First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
RECRUITING...and 7 more locations
Time frame: every 41-56 days(2 cycles ) until disease progression, death, or assessed up to 12 months after randomized enrollment.
Percentage of Participants With Adverse Events
Percentage of Participants With Adverse Events in different arms.
Time frame: Baseline until disease progression,death, or assessed up to 12 months after randomized enrollment.