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

February 21, 2021 updated by: Jie Li

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
334

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • Recruiting
        • Anhui Chest Hospital
        • Contact:
          • Mei Chai, MM
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Recruiting
        • Chongqing Cancer Hospital
        • Contact:
          • Fangfei Li
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Recruiting
        • Gansu Provincial Tumor Hospital
        • Contact:
          • Xudong Lei
    • Guangdong
      • Guanzhou, Guangdong, China, 510405
        • Recruiting
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Contact:
          • Hanrui Chen
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • xu sun
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Provincial Tumor Hospital
        • Contact:
          • Hong Wu
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
        • Contact:
          • Yan Lou
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital of Chinese Medicine
      • Xuzhou, Jiangsu, China, 221009
        • Recruiting
        • Xuzhou Central Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110032
        • Recruiting
        • The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
        • Contact:
          • Hong Gao
    • Shandong
      • Jinan, Shandong, China, 250014
        • Recruiting
        • The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
        • Contact:
          • Jiehui Li
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Longhua Hospital Shanghai University of Traditional Chinese Medicine
        • Contact:
          • Lihua Zhu
      • Shanghai, Shanghai, China, 200437
        • Recruiting
        • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
        • Contact:
          • Ling Xu, MD
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Provincial Cancer Hospital
      • Xian, Shanxi, China, 710038
        • Recruiting
        • The Fourth Military Medical University Tangdu Hospital
        • Contact:
          • Canjun Zhao
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Zhansheng Jiang
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • The First Affiliated Hospital of Zhejiang Chinese Medicine University
        • Contact:
          • Hong Pan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Kanglaite Injection + Chemotherapy
Participants receive Kanglaite Injection PLUS first-line chemotherapy.
Drug: Kanglaite Injection+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. The patients will also receive Kanglaite injection 200ml by IV infusion per day continuously for 14 days, commencing on the first day of chemotherapy.
Active Comparator: Chemotherapy
first-line chemotherapy.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival(PFS)
Time Frame: Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
Randomization until One year.
Quality of life of the patient
Time Frame: before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
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
Time Frame: before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
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
Time Frame: every 41-56 days(2 cycles ) until disease progression, death, or assessed up to 12 months after randomized enrollment.
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
Time Frame: Baseline until disease progression,death, or assessed up to 12 months after randomized enrollment.
Percentage of Participants With Adverse Events in different arms.
Baseline until disease progression,death, or assessed up to 12 months after randomized enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jie Li

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018YFC1707405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results of the study will be issued to publications through scientific journals and conference reports. The anonymized datasets used and/or analyzed during the current study are available from the sponsor-investigator on reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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