Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-22 @ 9:16 AM
Study NCT ID:
NCT04324151
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2020-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pembrolizumab Combined With Double Platinum Based Chemotherapy for Potentially Resectable 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-03-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2020-03-25', 'studyFirstSubmitQcDate': '2020-03-25', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'may 2020- may 2021 (1 year)', 'description': 'Progression free survival'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': 'may 2020- may 2021 (1 year)', 'description': 'Overall survival'}, {'measure': 'ORR', 'timeFrame': 'may 2020- may 2021 (1 year)', 'description': "To measure the patients's overall response rate"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to explore the efficacy and safety of Pembrolizumab Combined With Double Platinum-Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer', 'detailedDescription': 'Inclusion criteria:\n\ndiagnosed with Non-small cell lung cancer EGFR and ALK and ROS1 negative Treatment naive Potentially Resectable identified by MDT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology\n* Potentially Resectable NSCLC\n* Treatment Plan is Crizotinb or Standard Chemotherapy\n\nExclusion Criteria:\n\n* Patients with contraindication of chemotherapy\n* Pregnant or breast feeding women'}, 'identificationModule': {'nctId': 'NCT04324151', 'briefTitle': 'Pembrolizumab Combined With Double Platinum Based Chemotherapy for Potentially Resectable NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': 'Pembrolizumab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'PERSPECT'}}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongchang Zhang, MD', 'role': 'CONTACT', 'email': 'zhangyongchang@csu.edu.cn', 'phone': '+8613873123436', 'phoneExt': '+8613873123436'}], 'facility': 'Yongchang Zhang', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Yongchang Zhang, MD', 'role': 'CONTACT', 'email': 'zhangyongchang@csu.edu.cn', 'phone': '+8613873123436', 'phoneExt': '7+861383123436'}, {'name': 'Nong Yang, MD', 'role': 'CONTACT', 'email': 'yangnong0217@163.com', 'phone': '+8613055193557', 'phoneExt': '+8613873123436'}], 'overallOfficials': [{'name': 'Yongchang Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunan Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Yongchang Zhang', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}}