Clinical Trials /

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

NCT03986528

Description:

The purpose of this study is to evaluate the efficacy and safety of Kanglaite Injection for advanced non-small cell lung cancer(NSCLC).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

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

  • NSCLC

Interventions

DrugSynonymsArms
Kanglaite Injection+ChemotherapyKanglaite Injection + Chemotherapy
ChemotherapyChemotherapy

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

NameTypeDescriptionInterventions
Kanglaite Injection + ChemotherapyExperimentalParticipants receive Kanglaite Injection PLUS first-line chemotherapy.
  • Kanglaite Injection+Chemotherapy
ChemotherapyActive Comparatorfirst-line chemotherapy.
  • Chemotherapy

Eligibility Criteria

        Inclusion Criteria:

          -  Histological or cytological confirmation diagnosis of Non Small Cell Lung
             Cancer(NSCLC),Stage III-IV, no previous anticancer treatment, accept chemotherapy;

          -  18-75years old, male or female;

          -  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 treatment schedule.

        Exclusion Criteria:

          -  Presence of cerebral metastases;

          -  Confirmed EGFR, ALK, ROS1 mutation or PD-L1-positive expression (TPS≥ 50%) in genetic
             test;

          -  Participants with pleural effusion who need thoracic drainage or pleural injection of
             chemotherapy drugs;

          -  Current or preparing treatment of target therapy;

          -  Current or preparing treatment of radiotherapy to the thorax;

          -  Current or preparing treatment of tumor immunotherapy;

          -  Current treatment of lipid-decreasing;

          -  Pregnant woman or suckling period woman; fertile patients who are unwilling or unable
             to take effective contraceptive measures during the research and 6 months after the
             end of the research;

          -  History of mental disorders;

          -  Severe and uncontrolled organic lesion or infection, including cardiopulmonary
             failure, renal failure,and other reasons, which lead to poor tolerance of
             chemotherapy;

          -  Participated in other clinical trials of small molecule research drugs within 28 days
             before enrollment or participated in other clinical trials of big molecule research
             drugs within 3 months before enrollment;

          -  Known allergy or intolerance against study medications;

          -  With unlisted exclusion criteria but are considered not suitable 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

Last Updated

April 23, 2020