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

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ClinicalTrials.gov Identifier: NCT03986528
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : August 19, 2019
Sponsor:
Collaborators:
Ministry of Science and Technology of the People´s Republic of China
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Information provided by (Responsible Party):
Jie Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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).

Condition or disease Intervention/treatment Phase
NSCLC Drug: Kanglaite Injection+Chemotherapy Drug: Chemotherapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial on the Survival Advantage of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Kanglaite Injection + Chemotherapy
Participants receive Kanglaite Injection PLUS first-line chemotherapy.
Drug: Kanglaite Injection+Chemotherapy
Participants receive Kanglaite injection 200ml by intravenous (IV) infusion once everyday continuously for 14 days of each 21-28 day cycle for at least 2 cycles PLUS Investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle for at least 2 cycles) or nab-paclitaxel(260mg/m2 by IV infusion on Day 1 or Days 1,8 of each 21-28 day cycle for at least 2 cycles) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle for at least 2 cycles) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle for at least 2 cycles) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle for at least 2 cycles) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle for at least 2 cycles).

Active Comparator: Chemotherapy
first-line chemotherapy.
Drug: Chemotherapy
Participants receive Investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle for at least 2 cycles) or nab-paclitaxel(260mg/m2 by IV infusion on Day 1 or Days 1,8 of each 21-28 day cycle for at least 2 cycles) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle for at least 2 cycles) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle for at least 2 cycles) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle for at least 2 cycles) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle for at least 2 cycles).




Primary Outcome Measures :
  1. Progression Free Survival(PFS) [ Time Frame: Randomization until disease progression or death, whichever occurs first, assessed up to 36 months. ]
    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 :
  1. Objective Response Rate (ORR) [ Time Frame: Every two cycles (each cycle is 21 days) until disease progression or death, whichever occurs first, assessed up to 36 months. ]
    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.

  2. One-Year Survival Rate [ Time Frame: 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.

  3. Quality of life of the patient [ Time Frame: each 21 days until disease progression or death, whichever occurs first, assessed up to 36 months. ]
    This will be measured with validated questionnaires (EORTC-QLQ C30).

  4. Living ability of the patient [ Time Frame: each 21 days until disease progression or death, whichever occurs first, assessed up to 36 months. ]
    This will be measured with validated questionnaires(ECOG).

  5. Blood lipid [ Time Frame: Every two cycles (each cycle is 21 days) until disease progression or death, whichever occurs first, assessed up to 36 months. ]
    total cholesterol, triacylglycerides, high density cholesterol, low density cholesterol.

  6. Percentage of Participants With Adverse Events [ Time Frame: Baseline until disease progression or death, whichever occurs first, assessed up to 36 months. ]
    Percentage of Participants With Adverse Events in different arms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 expression positive (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 neurological or mental disorders;
  • Severe and uncontrolled organic lesion or infection, including cardiopulmonary failure, renal failure or other reasons, which lead to poor tolerance of chemotherapy;
  • Participated in other clinical trial of small molecule research drugs within 28 days prior to enrollment or participated in other clinical trial of big molecule research drugs within 3 months prior to enrollment;
  • Allergy or not tolerate to the test drug;
  • With unlisted exclusion criteria but are considered not suitable for the clinical study by researchers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986528


Contacts
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Contact: Gao rui ke +86 1088001192 gaork2015@126.com

Sponsors and Collaborators
Jie Li
Ministry of Science and Technology of the People´s Republic of China
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

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Responsible Party: Jie Li, Chief of Medical Department, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03986528     History of Changes
Other Study ID Numbers: 2018YFC1707405
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jie Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Advanced Non-Small Cell Lung Cancer
Kanglaite Injection

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms