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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Trial on the Survival Advantage of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)

Conditions
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NSCLC

Intervention / Treatment
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* Drug: Kanglaite Injection+Chemotherapy
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kanglaite Injection + Chemotherapy<br>Participants receive Kanglaite Injection PLUS first-line chemotherapy. | Drug: Kanglaite Injection+Chemotherapy<br>* 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.<br>|
| Active Comparator: Chemotherapy<br>first-line chemotherapy. | Drug: Chemotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 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). | 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. | 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. | Baseline until disease progression,death, or assessed up to 12 months after randomized enrollment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Non-Small Cell Lung Cancer, Kanglaite Injection, Chinese Herbal Medicine, Randomized Controlled Trial, Progression-free Survival