Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-03-26 @ 12:49 PM
Study NCT ID:
NCT01401192
Status:
UNKNOWN
Last Update Posted:
2011-07-25
First Post:
2011-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression
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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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': 'ESTIMATED', 'count': 304}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'lastUpdateSubmitDate': '2011-07-22', 'studyFirstSubmitDate': '2011-07-21', 'studyFirstSubmitQcDate': '2011-07-22', 'lastUpdatePostDateStruct': {'date': '2011-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'predictive value of TS expression', 'timeFrame': '12 months', 'description': 'To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value'}], 'secondaryOutcomes': [{'measure': 'response rate', 'timeFrame': '12 months', 'description': 'Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients'}, {'measure': 'response rate', 'timeFrame': '12 months', 'description': 'Whether the response rate of CP regimen is higher than that of CG regimen in TS- patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thymidylate synthase'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '26124486', 'type': 'DERIVED', 'citation': 'Sun JM, Ahn JS, Jung SH, Sun J, Ha SY, Han J, Park K, Ahn MJ. Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Nonsquamous Non-Small-Cell Lung Cancer: A Biomarker-Stratified Randomized Phase II Trial. J Clin Oncol. 2015 Aug 1;33(22):2450-6. doi: 10.1200/JCO.2014.59.9324. Epub 2015 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed nonsquamous NSCLC\n* Stage IIIb, IV or recurrent NSCLC\n* Age ≥ 18years\n* ECOG performance status of 0 to 1\n* Known TS immunohistochemical analysis data\n* At least one measurable lesion by RECIST 1.1\n* No previous chemotherapy or therapy with EGFR TKIs for advanced NSCLC\n* Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery\n* At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy\n* Adequate renal function: estimated creatinine clearance ≥ 50mL/min\n\nExclusion Criteria:\n\n* Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy.\n* Patients with post-obstructive pneumonia or uncontrolled serious infection'}, 'identificationModule': {'nctId': 'NCT01401192', 'briefTitle': 'Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A Randomized Phase II Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Non-squamous Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '2011-06-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TS positive cohort & Gem/Cis Tx arm', 'description': 'Among TS expression positive patients, some will be randomized to Gem/cis therapy', 'interventionNames': ['Drug: Gemcitabine plus cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TS+ cohort & Pem/Cis arm', 'description': 'Among patients with TS+, randomised to Pem/cis chemotherapy', 'interventionNames': ['Drug: pemetrexed plus cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TS negative cohort & Pem/Cis Tx arm', 'description': 'Among patients with TS-, some will be randomised to Pem/cis Tx arm', 'interventionNames': ['Drug: pemetrexed plus cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'TS negative cohort & Gem/Cis Tx arm', 'description': 'Among patients with TS-, some will be randomised to Gem/Cis Tx arm', 'interventionNames': ['Drug: Gemcitabine plus cisplatin']}], 'interventions': [{'name': 'Gemcitabine plus cisplatin', 'type': 'DRUG', 'description': 'Gemcitabine 1000mg/m2 D1, D8 \\& cisplatin 70mg/m2 D1 every 3 weeks', 'armGroupLabels': ['TS positive cohort & Gem/Cis Tx arm']}, {'name': 'pemetrexed plus cisplatin', 'type': 'DRUG', 'description': 'Pemetrexed 500mg/m2 \\& cisplatin 70mg/m2 D1 every 3 weeks', 'armGroupLabels': ['TS+ cohort & Pem/Cis arm']}, {'name': 'pemetrexed plus cisplatin', 'type': 'DRUG', 'description': 'pemetrexed 500mg/m2 \\& cisplatin 70mg/m2 every 3 weeks', 'armGroupLabels': ['TS negative cohort & Pem/Cis Tx arm']}, {'name': 'Gemcitabine plus cisplatin', 'type': 'DRUG', 'description': 'Gemcitabine 1000mg/m2 D1, D8 \\& cisplatin 70mg/m2 D1 every 3 weeks', 'armGroupLabels': ['TS negative cohort & Gem/Cis Tx arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Myung-Ju Ahn, M.D., Ph.D.', 'role': 'CONTACT'}, {'name': 'Jong-Mu Sun, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Myung-Ju Ahn, Pf', 'role': 'CONTACT', 'email': 'silkahn@skku.edu', 'phone': '822-3410-3459'}], 'overallOfficials': [{'name': 'Myung-Ju Ahn, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Myung-Ju Ahn, M.D., Ph.D.', 'oldOrganization': 'Samsung medical center'}}}}