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

NCT ID: NCT03986528

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-28
• Study Completion Date: 2022-05-31

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.

Conditions

NSCLC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Kanglaite Injection + Chemotherapy

Participants receive Kanglaite Injection PLUS first-line chemotherapy.

Group Type: EXPERIMENTAL

Kanglaite Injection+Chemotherapy

Intervention Type: DRUG

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

first-line chemotherapy.

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Technology of the People´s Republic of China

OTHER_GOV

Sponsor Role: collaborator

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

UNKNOWN

Sponsor Role: collaborator

Jie Li

OTHER

Sponsor Role: lead

Responsible Party

Jie Li

Chief of Medical Department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Anhui Chest Hospital

Hefei, Anhui, China

Site Status: RECRUITING

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Gansu Provincial Tumor Hospital

Lanzhou, Gansu, China

Site Status: RECRUITING

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guanzhou, Guangdong, China

Site Status: RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Hunan Academy of Traditional Chinese Medicine Affiliated Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Hunan Provincial Tumor Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Jiangsu Province Hospital of Chinese Medicine

Nanjing, Jiangsu, China

Site Status: RECRUITING

XuZhou Central Hospital

Xuzhou, Jiangsu, China

Site Status: RECRUITING

The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

Site Status: RECRUITING

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, China

Site Status: RECRUITING

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Site Status: RECRUITING

The Fourth Military Medical University Tangdu Hospital

Xian, Shanxi, China

Site Status: RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

The First Affiliated Hospital of Zhejiang Chinese Medicine University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Gao rui ke

Role: CONTACT

gaork2015@126.com

+86 1088001192

Facility Contacts

Mei Chai, MM

Role: primary

Fangfei Li

Role: primary

Xudong Lei

Role: primary

Hanrui Chen

Role: primary

Xu Sun

Role: primary

Yan Lou

Role: primary

Hong Wu

Role: primary

Li Zhang

Role: primary

Yong Liu

Role: primary

Hong Gao

Role: primary

Jiehui Li

Role: primary

Lihua Zhu

Role: primary

Ling Xu, MD

Role: primary

Yong Zhang

Role: primary

Canjun Zhao

Role: primary

Zhansheng Jiang

Role: primary

Hong Pan

Role: primary

References

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.

Reference Type: DERIVED

PMID: 33731199 (View on PubMed)

Other Identifiers

2018YFC1707405

Identifier Type: -

Identifier Source: org_study_id