Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT01783834
Status:
COMPLETED
Last Update Posted:
2016-02-11
First Post:
2013-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077156', 'term': 'Gefitinib'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-10', 'studyFirstSubmitDate': '2013-01-30', 'studyFirstSubmitQcDate': '2013-02-04', 'lastUpdatePostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '5years'}], 'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': '5years'}]}, 'conditionsModule': {'keywords': ['Pemetrexed', 'Gefitinib', 'iressa', 'alimta'], 'conditions': ['Previous Treated Metastatic Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cells pathologically diagnosed as histological or radical surgery or radiation therapy is not possible stage IIIB and stage IV non-small-cell lung cancer patients\n* second line\n* ECOG 0～2\n* Patients with normal liver function and renal function\n\nExclusion Criteria:\n\n* Patients with severe acute infection requiring antibiotic therapy\n* Patients who have received treatment in other areas of cancer within 5 years\n* During pregnancy and lactation patients'}, 'identificationModule': {'nctId': 'NCT01783834', 'briefTitle': 'Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients With Advanced Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '2008-GIRBA-1739'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'pemetrexed', 'description': 'pemetrexed', 'interventionNames': ['Drug: Pemetrexed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'gefitinib', 'description': 'gefitinib', 'interventionNames': ['Drug: Gefitinib']}], 'interventions': [{'name': 'Gefitinib', 'type': 'DRUG', 'otherNames': ['irressa'], 'description': 'compare progression free survivla rate and safety to both drugs', 'armGroupLabels': ['gefitinib']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'otherNames': ['alimta'], 'description': 'compare PFS rate, safety to both drugs', 'armGroupLabels': ['pemetrexed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon university Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Eun Kyung Cho', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}