Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT04284202
Status:
UNKNOWN
Last Update Posted:
2020-02-25
First Post:
2020-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PD-1 Combined With Dasatinib for as Third-line Treatment for ARID1A Mutation Advanced NSCLC
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069439', 'term': 'Dasatinib'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2020-02-23', 'studyFirstSubmitQcDate': '2020-02-24', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'Event driven, an expected average of 6 months'}], 'secondaryOutcomes': [{'measure': 'Overall survival(OS)', 'timeFrame': 'An expected average of 24months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NSCLC Stage IV', 'ARID1A', 'PD-1']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evalute the efficacy and safety of PD-1 antibody combined with Dasatinib as third-line therapy for NSCLC patients with ARID1A mutation until disease progression or intolerable toxicity or patients withdrawal of consent. The target sample size is 30+individuals. The primary endpoint of this study is PFS、ORR、OS and the secondary endpoint is toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- 1. Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures 2. over 18 years old 3. Metastatic (stage IV) NSCLCwith ARID1A mutation underwent 2 lines of prior treatment.\n\n4\\. World Health Organization (WHO) performance status 0-2 5. Adequate bone marrow reserve and organ function as demonstrated by complete blood count, biochemistry in blood and urine at baseline 6. ECG recording at baseline showing absence of any cardiac abnormality as per exclusion criterion #5 7. Female patients of childbearing potential must be using adequate contraceptive measures must not be breast feeding, and must have a negative pregnancy test prior to start of dosing.\n\nExclusion Criteria:\n\n\\- 1. Subjects with known EGFR and ALK mutations are excluded. 2. Subjects with untreated CNS metastases are excluded 3. Subjects with an active, known or suspected autoimmune disease. 4. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody or any other antibody targeting T cell co-regulatory pathways.\n\n5\\. Prior therapy with Dasatinib 6. Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results."}, 'identificationModule': {'nctId': 'NCT04284202', 'briefTitle': 'PD-1 Combined With Dasatinib for as Third-line Treatment for ARID1A Mutation Advanced NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'PD-1 Combined With Dasatinib for as Third-line Treatment for ARID1A Mutation Advanced NSCLC', 'orgStudyIdInfo': {'id': 'IOT-ARID1A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PD-1 plus Dasatinib', 'interventionNames': ['Drug: PD-1 plus Dasatinib']}], 'interventions': [{'name': 'PD-1 plus Dasatinib', 'type': 'DRUG', 'description': 'Toripalimub 240mg injection day1; Dasatinib 100mg po qd day1-day21. 3weeks is 1 cycle.', 'armGroupLabels': ['PD-1 plus Dasatinib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qingdao', 'country': 'China', 'contacts': [{'name': 'Xiaochun Zhang, MD', 'role': 'CONTACT', 'email': 'zxcgcp@126.com'}, {'name': 'Na Zhou, MD', 'role': 'CONTACT', 'email': 'zhounabb0912@126.com'}, {'name': 'Xiaochun Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chuantao Zhang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Helei Hou, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Precision Medicine Center', 'investigatorFullName': 'zhangxiaochun', 'investigatorAffiliation': 'The Affiliated Hospital of Qingdao University'}}}}