Description:
The purpose of this study is to evaluate the efficacy and safety of Kanglaite Injection for
advanced non-small cell lung cancer(NSCLC).
Title
- 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)
Clinical Trial IDs
- ORG STUDY ID:
2018YFC1707405
- NCT ID:
NCT03986528
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Kanglaite Injection+Chemotherapy | | Kanglaite Injection + Chemotherapy |
Chemotherapy | | Chemotherapy |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Kanglaite Injection + Chemotherapy | Experimental | Participants receive Kanglaite Injection PLUS first-line chemotherapy. | - Kanglaite Injection+Chemotherapy
|
Chemotherapy | Active Comparator | first-line chemotherapy. | |
Eligibility Criteria
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.
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free Survival(PFS) |
Time Frame: | Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first. |
Safety Issue: | |
Description: | 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
Measure: | Objective Response Rate (ORR) |
Time Frame: | Every two cycles (each cycle is 21-28 days) until disease progression, death, or 12 months after randomized enrollment, whichever occurs first. |
Safety Issue: | |
Description: | 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. |
Measure: | One-Year Survival Rate |
Time Frame: | Randomization until One year. |
Safety Issue: | |
Description: | One-year survival rate refers to the proportion of patients with a survival period of more than one year starting from randomized enrollment. |
Measure: | Quality of life of the patient |
Time Frame: | before and after each cycle of treatment, assessed up to 12 months after randomized enrollment |
Safety Issue: | |
Description: | This will be measured with validated questionnaires (EORTC-QLQ C30) and Lung Cancer Symptom Scale(LCSS). |
Measure: | Living ability of the patient |
Time Frame: | before and after each cycle of treatment, assessed up to 12 months after randomized enrollment |
Safety Issue: | |
Description: | This will be measured with validated questionnaires(ECOG) and Karnofsky performance status (KPS). |
Measure: | Blood lipid |
Time Frame: | every 41-56 days(2 cycles ) until disease progression, death, or assessed up to 12 months after randomized enrollment. |
Safety Issue: | |
Description: | total cholesterol, triacylglycerides, high density cholesterol, low density cholesterol. |
Measure: | Percentage of Participants With Adverse Events |
Time Frame: | Baseline until disease progression,death, or assessed up to 12 months after randomized enrollment. |
Safety Issue: | |
Description: | Percentage of Participants With Adverse Events in different arms. |
Details
Phase: | Phase 4 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Jie Li |
Trial Keywords
- Advanced Non-Small Cell Lung Cancer
- Kanglaite Injection
- Chinese Herbal Medicine
- Randomized Controlled Trial
- Progression-free Survival
Last Updated
February 23, 2021