Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-28 @ 4:48 PM
Study NCT ID:
NCT01449357
Status:
WITHDRAWN
Last Update Posted:
2011-10-10
First Post:
2011-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors
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': 'C546618', 'term': 'zalutumumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Trial never initiated', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'lastUpdateSubmitDate': '2011-10-07', 'studyFirstSubmitDate': '2011-09-29', 'studyFirstSubmitQcDate': '2011-10-07', 'lastUpdatePostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response (OR) defined as complete response (CR) or partial response (PR) according to the RECIST criteria (revised version 1.1) within 6 months.', 'timeFrame': 'within 6 months'}], 'secondaryOutcomes': [{'measure': 'Disease Control defined as CR, PR or Stable Disease (SD) according to the RECIST criteria (revised version 1.1) within 6 months.', 'timeFrame': 'within 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NSCLC', 'Zalutumumab', 'Efficacy', 'Safety'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients with Non-Small Cell Lung Cancer who have Progressive Disease after Treatment with Tyrosine Kinase Inhibitors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have documented disease progression after TKI treatment (verified by CT scan and/or MRI according to RECIST).\n\nExclusion Criteria:\n\n* Estimated life expectancy of less than 3 months.\n* Received the following treatments within 2 weeks prior to Visit 2:\n\n * Cytotoxic or cytostatic anti-cancer chemotherapy\n * Total resection or irradiation of the target lesion\n * Any investigational agent'}, 'identificationModule': {'nctId': 'NCT01449357', 'briefTitle': 'Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genmab'}, 'officialTitle': 'A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients With Non-Small Cell Lung Cancer Who Have Progressive Disease After Treatment With Tyrosine Kinase Inhibitors', 'orgStudyIdInfo': {'id': 'GEN210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'zalutumumab', 'interventionNames': ['Drug: zalutumumab']}], 'interventions': [{'name': 'zalutumumab', 'type': 'DRUG', 'description': 'IV infusion, 16mg/kg on weekly basis until DP', 'armGroupLabels': ['zalutumumab']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Not applicable, Study cancelled', 'role': 'STUDY_CHAIR', 'affiliation': 'H. Lee Moffitt Cancer Center, Tampa, Florida, USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genmab', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}