Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 9:38 PM
Study NCT ID:
NCT06736561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-16
First Post:
2024-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Real-world Clinical Study on the Efficacy and Safety of Ensartinib As Neoadjuvant Treatment for Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer (NSCLC) Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2024-12-12', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MPR', 'timeFrame': '6month', 'description': 'Main pathological remission rate'}], 'secondaryOutcomes': [{'measure': 'pCR', 'timeFrame': '6month', 'description': 'Pathological complete response rate'}, {'measure': '2-year disease-free survival rate', 'timeFrame': '2year', 'description': '2-year disease-free survival rate'}, {'measure': 'ORR', 'timeFrame': '1year', 'description': 'Objective response rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALK Positive', 'Ensartinib', 'NSCLC', 'Neoadjuvant therapy'], 'conditions': ['ALK Positive', 'Ensartinib', 'NSCLC', 'Neoadjuvant Therapy']}, 'descriptionModule': {'briefSummary': 'Explore the efficacy and safety of Ensartinib in neoadjuvant treatment for ALK-positive non-small cell lung cancer in the real world.This is a real-world study of patients receiving enshatinib-based neoadjuvant therapy with R0 resection, divided into retrospective cohort 1, prospective cohort 2, and prospective cohort 3. The dose, duration, and whether to combine or sequentially treat enshatinib were clinical decisions made by the investigator on a patient-specific basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ALK+', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Cohort 1: Female or male aged \\>=18 years;\n2. Cohort 1: Received neoadjuvant treatment with Ensartinib before the project started;\n3. Cohort 1: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;\n4. Cohort 1: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy.\n5. Cohort 2: Female or male aged \\>=18 years;\n6. Cohort 2: Intended to receive Ensartinib monotherapy as neoadjuvant treatment for 6-12 weeks;\n7. Cohort 2: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;\n8. Cohort 2: Confirmed ALK positive by immunohistochemistry (IFL), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;\n9. Cohort 2: Signed informed consent form;\n10. Cohort 3: Female or male aged \\>=18 years;\n11. Cohort 3: Intended to receive neoadjuvant treatment including Ensartinib, but not meeting the inclusion criteria for Cohort 2;\n12. Cohort 3: Diagnosed with clinical stage II-III resectable or potentially resectable ALK-positive NSCLC before neoadjuvant treatment;\n13. Cohort 3: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;\n14. Cohort 3: Signed informed consent form.\n\nExclusion Criteria:\n\n1. Cohort 1: Patients who have received treatment with Ensartinib after the project has started;\n2. Cohort 1: Patients who have received Ensartinib treatment but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;\n3. Cohort 1: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;\n4. Cohort 1: Patients who are participating in other clinical studies outside of this research;\n5. Cohort 1: Other circumstances deemed unsuitable for enrollment by the researchers.\n6. Cohort 2: Patients who have received Ensartinib treatment before the study started;\n7. Cohort 2: Patients who have received other systemic treatments besides Ensartinib;\n8. Cohort 2: Neoadjuvant treatment cycles less than 6 weeks or more than 12 weeks;\n9. Cohort 2: Patients who have received Ensartinib monotherapy but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;\n10. Cohort 2: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;\n11. Cohort 2: Patients who are participating in other clinical studies outside of this research;\n12. Cohort 2: Other circumstances deemed unsuitable for enrollment by the researchers.\n13. Cohort 3: Patients who have received neoadjuvant treatment containing Ensartinib but meet the enrollment criteria for Cohort 2;\n14. Cohort 3: Patients who have received treatment containing Ensartinib but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;\n15. Cohort 3: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;\n16. Cohort 3: Patients who are participating in other clinical studies outside of this research;\n17. Cohort 3: Other circumstances deemed unsuitable for enrollment by the researchers.'}, 'identificationModule': {'nctId': 'NCT06736561', 'briefTitle': 'A Multicenter Real-world Clinical Study on the Efficacy and Safety of Ensartinib As Neoadjuvant Treatment for Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer (NSCLC) Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Harbin Medical University'}, 'officialTitle': 'A Multicenter Real-world Clinical Study on the Efficacy and Safety of Ensartinib As Neoadjuvant Treatment for Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer (NSCLC) Patients.', 'orgStudyIdInfo': {'id': '2024-275-IIT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Data on the efficacy and safety of patients who had previously used enshatinib in the neoadjuvant phase were retrospectively collected'}, {'label': 'Cohort 2', 'description': 'Akl-positive patients received enshatinib monotherapy neoadjuvant therapy for 6-12 weeks'}, {'label': 'Cohort 3', 'description': 'Alk-positive patients received neoadjuvant therapy that included enshatinib and did not meet cohort 2 inclusion criteria'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ma', 'role': 'CONTACT', 'email': 'jianqunma@aliyun.com', 'phone': '86+ 18646101888'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'archiater', 'investigatorFullName': 'Jianqun Ma', 'investigatorAffiliation': 'Harbin Medical University'}}}}