Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT02827357
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2016-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Responses to Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 'ACTUAL', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-07', 'studyFirstSubmitDate': '2016-07-06', 'studyFirstSubmitQcDate': '2016-07-07', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Median progression-free survival (PFS) with conventional chemotherapy', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This chart review describe the response to systemic chemotherapy of patients with non-small cell lung cancer (NSCLC) harbouring a known somatic activating human epidermal growth factor receptor 2 (HER2) mutation. The analysis of this data will provide an initial description of the response to systemic chemotherapy in patients with NSCLC harboring an activating HER2 mutation in order to inform the design and powering of future randomized controlled clinical trials of HER2-directed therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with advanced nonsmall-cell lung cancer (NSCLC), a known HER2 exon-20 insertion, treated with chemotherapy and/or HER2-targeted drugs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with advanced nonsmall-cell lung cancer\n* known HER2 exon-20 insertion\n* treated with chemotherapy and/or HER2-targeted drugs\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02827357', 'briefTitle': 'Responses to Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Review of Responses to Systemic Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation', 'orgStudyIdInfo': {'id': '14 7305 03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No specific intervention', 'type': 'OTHER', 'description': 'Clinical, drug and data collection : characteristics of patients (age, sex and histology), non HER 2-directed treatments including response and duration of response'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MAZIERES Julien, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}