Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT04830202
Status:
AVAILABLE
Last Update Posted:
2025-10-03
First Post:
2021-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Access to Telisotuzumab Vedotin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Germany', 'Hong Kong', 'Israel', 'United States']}, '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': 'C000626235', 'term': 'telisotuzumab vedotin'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 3}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2021-03-31', 'studyFirstSubmitQcDate': '2021-03-31', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Non-Small Cell Lung Cancer (NSCLC)', 'Telisotuzumab vedotin', 'ABBV-399', 'Expanded Access', 'Pre-approval Access', 'Compassionate Use', 'Special Access Program', 'Named Patient Basis', 'Special Access Scheme'], 'conditions': ['Non-Small Cell Lung Cancer (NSCLC)']}, 'descriptionModule': {'briefSummary': "This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Telisotuzumab vedotin prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria."}, 'eligibilityModule': {'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- The participant must not be eligible for a telisotuzumab vedotin clinical trial.'}, 'identificationModule': {'nctId': 'NCT04830202', 'briefTitle': 'Expanded Access to Telisotuzumab Vedotin', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Expanded Access to Telisotuzumab Vedotin', 'orgStudyIdInfo': {'id': 'C20-503'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Telisotuzumab vedotin', 'type': 'DRUG', 'otherNames': ['ABBV-399'], 'description': 'Intravenous Infusion'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}