Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 10:47 AM
Study NCT ID:
NCT03986528
Status:
UNKNOWN
Last Update Posted:
2021-02-23
First Post:
2019-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 334}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-21', 'studyFirstSubmitDate': '2019-05-30', 'studyFirstSubmitQcDate': '2019-06-11', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival(PFS)', 'timeFrame': 'Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.', 'description': 'Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)'}], 'secondaryOutcomes': [{'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.', 'description': '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.'}, {'measure': 'One-Year Survival Rate', 'timeFrame': 'Randomization until One year.', 'description': 'One-year survival rate refers to the proportion of patients with a survival period of more than one year starting from randomized enrollment.'}, {'measure': 'Quality of life of the patient', 'timeFrame': 'before and after each cycle of treatment, assessed up to 12 months after randomized enrollment', 'description': 'This will be measured with validated questionnaires (EORTC-QLQ C30) and Lung Cancer Symptom Scale(LCSS).'}, {'measure': 'Living ability of the patient', 'timeFrame': 'before and after each cycle of treatment, assessed up to 12 months after randomized enrollment', 'description': 'This will be measured with validated questionnaires(ECOG) and Karnofsky performance status (KPS).'}, {'measure': 'Blood lipid', 'timeFrame': 'every 41-56 days(2 cycles ) until disease progression, death, or assessed up to 12 months after randomized enrollment.', 'description': 'total cholesterol, triacylglycerides, high density cholesterol, low density cholesterol.'}, {'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'Baseline until disease progression,death, or assessed up to 12 months after randomized enrollment.', 'description': 'Percentage of Participants With Adverse Events in different arms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Non-Small Cell Lung Cancer', 'Kanglaite Injection', 'Chinese Herbal Medicine', 'Randomized Controlled Trial', 'Progression-free Survival'], 'conditions': ['NSCLC']}, 'referencesModule': {'references': [{'pmid': '33731199', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Kanglaite Injection for advanced non-small cell lung cancer(NSCLC).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A Histological or cytological confirmed diagnosis of Stage III-IV NSCLC, with no history of anticancer treatment including chemotherapy;\n* Male or female aged 18-75years;\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-2;\n* Life expectancy of at least 3 months;\n* At least one radiographically measurable lesion per RECIST 1.1;\n* Willing to join the clinic trail and sign informed consent;\n* Able to comply with scheduled visits and treatments.\n\nExclusion Criteria:\n\n* Presence of cerebral metastases;\n* 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;\n* Participants with malignant pleural effusion underwent intrapleural injection chemotherapy;\n* Current undergoing or preparing for treatment with target therapy;\n* Current undergoing or preparing for radiotherapy to the thorax;\n* Current undergoing or preparing treatment with tumor immunotherapy;\n* Currently undergoing lipid-decreasing treament;\n* Pregnant or breastfeeding woman;\n* Fertile patients who are unwilling or unable to take effective contraceptive measures during the research period until 6 months after the study end later;\n* A history of mental disorders；\n* Severe and uncontrolled organic lesion or infection, including but not limited to cardiopulmonary failure and renal failure，which lead to poor tolerance of chemotherapy;\n* 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;\n* Known allergy or intolerance to study medications;\n* Considered to be otherwise unsuitable for the clinical study by researchers.'}, 'identificationModule': {'nctId': 'NCT03986528', 'briefTitle': 'Clinical Trial of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'Clinical Trial on the Survival Advantage of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': '2018YFC1707405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kanglaite Injection + Chemotherapy', 'description': 'Participants receive Kanglaite Injection PLUS first-line chemotherapy.', 'interventionNames': ['Drug: Kanglaite Injection+Chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy', 'description': 'first-line chemotherapy.', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'Kanglaite Injection+Chemotherapy', 'type': 'DRUG', 'description': "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.", 'armGroupLabels': ['Kanglaite Injection + Chemotherapy']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'description': "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.", 'armGroupLabels': ['Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230022', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mei Chai, MM', 'role': 'CONTACT'}], 'facility': 'Anhui Chest Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '400030', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fangfei Li', 'role': 'CONTACT'}], 'facility': 'Chongqing Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '730050', 'city': 'Lanzhou', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xudong Lei', 'role': 'CONTACT'}], 'facility': 'Gansu Provincial Tumor Hospital', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '510405', 'city': 'Guanzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hanrui Chen', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Guangzhou University of Chinese Medicine', 'geoPoint': {'lat': 23.06828, 'lon': 113.37117}}, {'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xu Sun', 'role': 'CONTACT'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Lou', 'role': 'CONTACT'}], 'facility': 'Hunan Academy of Traditional Chinese Medicine Affiliated Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Wu', 'role': 'CONTACT'}], 'facility': 'Hunan Provincial Tumor Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Zhang', 'role': 'CONTACT'}], 'facility': 'Jiangsu Province Hospital of Chinese Medicine', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '221009', 'city': 'Xuzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Liu', 'role': 'CONTACT'}], 'facility': 'XuZhou Central Hospital', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '110032', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Gao', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiehui Li', 'role': 'CONTACT'}], 'facility': 'The Affiliated Hospital of Shandong University of Traditional Chinese Medicine', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lihua Zhu', 'role': 'CONTACT'}], 'facility': 'Longhua Hospital Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200437', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ling Xu, MD', 'role': 'CONTACT'}], 'facility': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '030000', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Zhang', 'role': 'CONTACT'}], 'facility': 'Shanxi Provincial Cancer Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '710038', 'city': 'Xian', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Canjun Zhao', 'role': 'CONTACT'}], 'facility': 'The Fourth Military Medical University Tangdu Hospital'}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhansheng Jiang', 'role': 'CONTACT'}], 'facility': 'Tianjin Medical University Cancer Institute & Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Pan', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Zhejiang Chinese Medicine University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Gao rui ke', 'role': 'CONTACT', 'email': 'gaork2015@126.com', 'phone': '+86 1088001192'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jie Li', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Technology of the People´s Republic of China', 'class': 'OTHER_GOV'}, {'name': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief of Medical Department', 'investigatorFullName': 'Jie Li', 'investigatorAffiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}}