Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-05 @ 5:24 PM
Study NCT ID:
NCT04144569
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2019-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PD-1 Combined With Pyrotinib for Chemotherapy Failure HER2 Insertion Mutation Advanced NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000622954', 'term': 'pyrotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2019-10-28', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'Approximately 1 years', 'description': 'Progression free survival'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'Approximately 1 years', 'description': "To measure the patients's overall response rate"}, {'measure': 'OS', 'timeFrame': 'Approximately 1 years', 'description': 'Overall survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HER2 Insertion Mutation Positive Advanced NSCLC']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and effectiveness of PD-1 Combined With Pyrotinib for First-line chemotherapy failed HER2 Insertion Mutation Positive Advanced Non-small Cell Lung Cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced non-small cell lung cancer confirmed by histology or cytology\n* HER2 insertion mutation-positive\n* Failure with first-line standard chemotherapy\n* with measurable lesions.\n\nExclusion Criteria:\n\n* no measurable tumor lesions\n* Patients received PD-1 or Pyrotinib before'}, 'identificationModule': {'nctId': 'NCT04144569', 'briefTitle': 'PD-1 Combined With Pyrotinib for Chemotherapy Failure HER2 Insertion Mutation Advanced NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': 'the Effectiveness and Safety Study on PD-1 Combined With Pyrotinib for First-line Chemotherapy Failed HER2 Insertion Mutation Advanced Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'POETHIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PD-1 Combined With Pyrotinib', 'description': 'PD-1 combined With pyrotinib used fo first-line chemotherapy failedr HER2 Insertion mutation positive advanced NSCLC', 'interventionNames': ['Drug: PD-1 Combined With Pyrotinib']}], 'interventions': [{'name': 'PD-1 Combined With Pyrotinib', 'type': 'DRUG', 'description': 'PD-1 Combined With Pyrotinib', 'armGroupLabels': ['PD-1 Combined With Pyrotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Nong Yang, MD', 'role': 'CONTACT', 'email': 'yangnong0217@163.com', 'phone': '+86 731 89762323'}, {'name': 'Yongchang Zhang, MD', 'role': 'CONTACT', 'email': 'zhangyongchang@csu.edu.cn', 'phone': '+86 731 89762327'}, {'name': 'Nong Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yongchang Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hunan Provincal Tumor Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Yongchang Zhang, MD', 'role': 'CONTACT', 'email': 'zhangyongchang@csu.edu.cn', 'phone': '+8613873123436', 'phoneExt': '+8613873123436'}, {'name': 'Xiangyu Zhang, PhD', 'role': 'CONTACT', 'email': '514775505@qq.com'}], 'overallOfficials': [{'name': 'Yongchang Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunan Province Tumor Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yongchang Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yongchang Zhang', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}}