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)
1 other identifier
interventional
334
1 country
17
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2019
Typical duration for phase_4
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2019
CompletedFirst Posted
Study publicly available on registry
June 14, 2019
CompletedStudy Start
First participant enrolled
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedFebruary 23, 2021
February 1, 2021
2.6 years
May 30, 2019
February 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Objective Response Rate (ORR)
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
Randomization until One year.
Quality of life of the patient
before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
Living ability of the patient
before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
Blood lipid
every 41-56 days(2 cycles ) until disease progression, death, or assessed up to 12 months after randomized enrollment.
- +1 more secondary outcomes
Study Arms (2)
Kanglaite Injection + Chemotherapy
EXPERIMENTALParticipants receive Kanglaite Injection PLUS first-line chemotherapy.
Chemotherapy
ACTIVE COMPARATORfirst-line chemotherapy.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Anhui Chest Hospital
Hefei, Anhui, 230022, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Gansu Provincial Tumor Hospital
Lanzhou, Gansu, 730050, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guanzhou, Guangdong, 510405, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
Changsha, Hunan, 410013, China
Hunan Provincial Tumor Hospital
Changsha, Hunan, 410013, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, 210029, China
XuZhou Central Hospital
Xuzhou, Jiangsu, 221009, China
The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, 110032, China
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250014, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032, China
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030000, China
The Fourth Military Medical University Tangdu Hospital
Xian, Shanxi, 710038, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital of Zhejiang Chinese Medicine University
Hangzhou, Zhejiang, 310006, China
Related Publications (1)
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.
PMID: 33731199DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief of Medical Department
Study Record Dates
First Submitted
May 30, 2019
First Posted
June 14, 2019
Study Start
August 28, 2019
Primary Completion
March 31, 2022
Study Completion
May 31, 2022
Last Updated
February 23, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
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.