Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT05132218
Status:
UNKNOWN
Last Update Posted:
2021-11-24
First Post:
2021-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "1. The patient's tumor tissue sample before taking Ensatinib\n2. The patient's baseline blood sample within the first week before taking Ensantinib\n3. Blood samples of patients 4-6 weeks after taking Ensatinib\n4. Blood samples within 4 weeks after the patient's disease progression"}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-16', 'studyFirstSubmitDate': '2021-10-26', 'studyFirstSubmitQcDate': '2021-11-16', 'lastUpdatePostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': '2021.09.27-2024.12.30'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '2021.09.27-2024.12.30'}, {'measure': 'Time-to-TreatmentFailure', 'timeFrame': '2021.09.27-2024.12.30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ALK Positive', 'NSCLC Stage IIIB', 'NSCLC Stage IV']}, 'descriptionModule': {'briefSummary': 'The experimental design is exploratory, single-arm, multi-center, real-world research.\n\nEnsatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world, Ensatinib is effective for the newly treated ALK+ advanced NSCLC\n\n1. Efficacy and safety;\n2. The relationship between molecular mechanism and curative effect;\n3. Ensatinib resistance mechanism;', 'detailedDescription': 'Enrolled patients:\n\n1. stage IIIB or stage IV NSCLC\n2. Each center confirmed ALK+ by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);\n3. Without any ALK-TKI treatment; Study endpoint\n\nPrimary endpoint:\n\nAccording to the RECIST1.1 standard, the progression-free survival (PFS) assessed by the investigator;\n\nSecondary endpoint:\n\nAccording to the RECIST1.1 standard, the objective response rate (ORR) evaluated by the investigator; the time to treatment failure (TTF); according to the RECIST1.1 standard, the ORR and PFS of patients with different ALK fusion subtypes evaluated by the investigator; total Lifetime (OS); safety;\n\nExploratory endpoint:\n\nThe correlation between the biomarkers in blood or/and tissue samples and the efficacy of Ensatinib; the resistance mechanism of Ensatinib;\n\nThe sample size is determined:\n\nThe plan is to analyze 60-80 patients with EML4-ALK fusion v1 and v3 subtypes. Based on the proportion of patients with both subtypes in ALK-positive patients, the proportion is about 40%. Based on the 20% dropout rate, the plan is to include ALK without distinction. 180 patients with fusion subtype; statistical methods:'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Single arm real world study of non-small cell lung cancer; stage IIIB or stage IV ALK positive NSCLC；', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. stage IIIB or stage IV NSCLC by histology or cytology;\n2. All centers confirmed ALK positive by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);\n3. Without any ALK-TKI treatment;\n4. Voluntarily and capable of following the trial and follow-up procedures;\n5. Able to understand the nature of the trial, and be able to complete the signing of a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Pereceived any ALK-TKI treatment ; 2. Received any chemotherapy within 4 weeks, or underwent major surgery or radiotherapy within the last 14 days; 3. The investigator believes that the patient is not suitable for Ensatinib treatment.\n\nHad a stem cell or organ transplant. 4. Having serious cardiovascular disease, including but not limited to: 5.Sino - QTcF interval ≥450 ms or other significant ECG abnormalities. According to the study, researchers either ruled that hypertension was poorly controlled (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100mmHg).\n\n6\\. Dysphagia, active gastrointestinal disease, or other disease that significantly affects drug absorption, distribution, metabolism, and excretion.\n\n7\\. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radioactive pneumonia requiring steroid treatment, or any indication of clinically active interstitial lung disease.'}, 'identificationModule': {'nctId': 'NCT05132218', 'acronym': 'EFLRWR', 'briefTitle': 'Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'Prospective Exploratory Real World Study of Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'BD-EN-IV002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ensatinib for treated patients with ALK-positive advanced non-small cell lung cancer', 'description': 'Ensatinib 225mg QD Until the disease progresses or intolerance', 'interventionNames': ['Drug: Ensatinib']}], 'interventions': [{'name': 'Ensatinib', 'type': 'DRUG', 'otherNames': ['BD-EN-IV002'], 'description': 'Prospective, exploratory, single-arm, multi-center, real-world research', 'armGroupLabels': ['Ensatinib for treated patients with ALK-positive advanced non-small cell lung cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100176', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Li, PhD', 'role': 'CONTACT', 'email': 'xiaotong10241@sina.com', 'phone': '010-88196391'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jun Zhao, PhD', 'role': 'CONTACT', 'email': 'ohjerry@163.com', 'phone': '13521469335'}, {'name': 'Xue Yang Yang', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Betta Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jun Zhao', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}