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

Primary Purpose

NSCLC

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Kanglaite Injection+Chemotherapy
Chemotherapy
Sponsored by
Jie Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC focused on measuring Advanced Non-Small Cell Lung Cancer, Kanglaite Injection, Chinese Herbal Medicine, Randomized Controlled Trial, Progression-free Survival

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anhui Chest HospitalRecruiting
  • Chongqing Cancer HospitalRecruiting
  • Gansu Provincial Tumor HospitalRecruiting
  • The First Affiliated Hospital of Guangzhou University of Chinese MedicineRecruiting
  • Henan Cancer HospitalRecruiting
  • Hunan Academy of Traditional Chinese Medicine Affiliated HospitalRecruiting
  • Hunan Provincial Tumor HospitalRecruiting
  • Jiangsu Province Hospital of Chinese MedicineRecruiting
  • XuZhou Central HospitalRecruiting
  • The First Affiliated Hospital of Liaoning University of Traditional Chinese MedicineRecruiting
  • The Affiliated Hospital of Shandong University of Traditional Chinese MedicineRecruiting
  • Longhua Hospital Shanghai University of Traditional Chinese MedicineRecruiting
  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese MedicineRecruiting
  • Shanxi Provincial Cancer HospitalRecruiting
  • The Fourth Military Medical University Tangdu HospitalRecruiting
  • Tianjin Medical University Cancer Institute & HospitalRecruiting
  • The First Affiliated Hospital of Zhejiang Chinese Medicine UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kanglaite Injection + Chemotherapy

Chemotherapy

Arm Description

Participants receive Kanglaite Injection PLUS first-line chemotherapy.

first-line chemotherapy.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
Quality of life of the patient
This will be measured with validated questionnaires (EORTC-QLQ C30) and Lung Cancer Symptom Scale(LCSS).
Living ability of the patient
This will be measured with validated questionnaires(ECOG) and Karnofsky performance status (KPS).
Blood lipid
total cholesterol, triacylglycerides, high density cholesterol, low density cholesterol.
Percentage of Participants With Adverse Events
Percentage of Participants With Adverse Events in different arms.

Full Information

First Posted
May 30, 2019
Last Updated
February 21, 2021
Sponsor
Jie Li
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
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1. Study Identification

Unique Protocol Identification Number
NCT03986528
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 28, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jie Li
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC
Keywords
Advanced Non-Small Cell Lung Cancer, Kanglaite Injection, Chinese Herbal Medicine, Randomized Controlled Trial, Progression-free Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kanglaite Injection + Chemotherapy
Arm Type
Experimental
Arm Description
Participants receive Kanglaite Injection PLUS first-line chemotherapy.
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
first-line chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Kanglaite Injection+Chemotherapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival(PFS)
Description
Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time Frame
Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
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.
Time Frame
Every two cycles (each cycle is 21-28 days) until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
Title
One-Year Survival Rate
Description
One-year survival rate refers to the proportion of patients with a survival period of more than one year starting from randomized enrollment.
Time Frame
Randomization until One year.
Title
Quality of life of the patient
Description
This will be measured with validated questionnaires (EORTC-QLQ C30) and Lung Cancer Symptom Scale(LCSS).
Time Frame
before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
Title
Living ability of the patient
Description
This will be measured with validated questionnaires(ECOG) and Karnofsky performance status (KPS).
Time Frame
before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
Title
Blood lipid
Description
total cholesterol, triacylglycerides, high density cholesterol, low density cholesterol.
Time Frame
every 41-56 days(2 cycles ) until disease progression, death, or assessed up to 12 months after randomized enrollment.
Title
Percentage of Participants With Adverse Events
Description
Percentage of Participants With Adverse Events in different arms.
Time Frame
Baseline until disease progression,death, or assessed up to 12 months after randomized enrollment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gao rui ke
Phone
+86 1088001192
Email
gaork2015@126.com
Facility Information:
Facility Name
Anhui Chest Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Chai, MM
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fangfei Li
Facility Name
Gansu Provincial Tumor Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xudong Lei
Facility Name
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510405
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanrui Chen
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Sun
Facility Name
Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Lou
Facility Name
Hunan Provincial Tumor Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Wu
Facility Name
Jiangsu Province Hospital of Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhang
Facility Name
XuZhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Liu
Facility Name
The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Gao
Facility Name
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiehui Li
Facility Name
Longhua Hospital Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihua Zhu
Facility Name
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200437
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Xu, MD
Facility Name
Shanxi Provincial Cancer Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Zhang
Facility Name
The Fourth Military Medical University Tangdu Hospital
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Canjun Zhao
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhansheng Jiang
Facility Name
The First Affiliated Hospital of Zhejiang Chinese Medicine University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Pan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33731199
Citation
Gao R, Zhang Y, Hou W, Li J, Zhu G, Zhang X, Xu B, Wu Z, Wang H. Combination of first-line chemotherapy with Kanglaite injections versus first-line chemotherapy alone for advanced non-small-cell lung cancer: study protocol for an investigator-initiated, multicenter, open-label, randomized controlled trial. Trials. 2021 Mar 17;22(1):214. doi: 10.1186/s13063-021-05169-w.
Results Reference
derived

Learn more about this trial

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

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