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

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03986528
• Other study ID #: 2018YFC1707405
• Status: Recruiting
• Phase: Phase 4
• Start date: August 28, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2021
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Gao rui ke
• Phone: +86 1088001192
• Email: gaork2015[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 334
• Est. completion date: May 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• NSCLC

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Hunan Academy of Traditional Chinese Medicine Affiliated Hospital	Changsha	Hunan
China	Hunan Provincial Tumor Hospital	Changsha	Hunan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Guanzhou	Guangdong
China	The First Affiliated Hospital of Zhejiang Chinese Medicine University	Hangzhou	Zhejiang
China	Anhui Chest Hospital	Hefei	Anhui
China	The Affiliated Hospital of Shandong University of Traditional Chinese Medicine	Jinan	Shandong
China	Gansu Provincial Tumor Hospital	Lanzhou	Gansu
China	Jiangsu Province Hospital of Chinese Medicine	Nanjing	Jiangsu
China	Longhua Hospital Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine	Shenyang	Liaoning
China	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	The Fourth Military Medical University Tangdu Hospital	Xian	Shanxi
China	XuZhou Central Hospital	Xuzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (3)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.