Clinical trial NCT03986528: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: NSCLC
Keywords: Advanced Non-Small Cell Lung Cancer
Kanglaite Injection
Chinese Herbal Medicine
Randomized Controlled Trial
Progression-free Survival
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
name: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
First posted: 2019-06-14
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Every two cycles (each cycle is 21-28 days) until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
measure: One-Year Survival Rate
timeFrame: Randomization until One year.
measure: Quality of life of the patient
timeFrame: before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
measure: Living ability of the patient
timeFrame: before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
measure: Blood lipid
timeFrame: every 41-56 days(2 cycles ) until disease progression, death, or assessed up to 12 months after randomized enrollment.
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline until disease progression,death, or assessed up to 12 months after randomized enrollment.
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Chest Hospital
state: Anhui
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Lanzhou
country: China
facility: Gansu Provincial Tumor Hospital
state: Gansu
city: Guanzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
state: Hunan
city: Changsha
country: China
facility: Hunan Provincial Tumor Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Chinese Medicine
state: Jiangsu
city: Xuzhou
country: China
facility: XuZhou Central Hospital
state: Jiangsu
city: Shenyang
country: China
facility: The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Jinan
country: China
facility: The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
state: Shandong
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Xian
country: China
facility: The Fourth Military Medical University Tangdu Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang Chinese Medicine University
state: Zhejiang
Study officials:
References:
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.