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

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: Unknown
• Conditions: NSCLC
• Intervention / Treatment: Drug: Kanglaite Injection+Chemotherapy; Drug: Chemotherapy

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: Interventional
• Enrollment (Anticipated): 334
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)	Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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	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	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

• 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2019
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 21, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Chinese Herbal Medicine; Randomized Controlled Trial; Advanced Non-Small Cell Lung Cancer; Progression-free Survival; Kanglaite Injection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID 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