Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-20 @ 4:24 PM
Study NCT ID:
NCT02399566
Status:
UNKNOWN
Last Update Posted:
2015-03-26
First Post:
2015-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Erlotinib and Pemetrexed for Maintenance Treatment in Lung Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2015-03-22', 'studyFirstSubmitQcDate': '2015-03-25', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'two years'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'two years'}, {'measure': 'Clinical benefit rate (CBR)', 'timeFrame': 'two years'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'two years'}, {'measure': 'The adverse reaction', 'timeFrame': 'two years'}, {'measure': 'Time to progression (TTP)', 'timeFrame': 'two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['erlotinib', 'pemetrexed', 'maintenance therapy'], 'conditions': ['Lung Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare effects of erlotinib and pemetrexed as maintenance therapy for lung adenocarcinoma. Primary Outcome is the progression free survival (PFS). Based on prediction of different potential benefit groups, this study may help the oncologist to optimize and improve the maintenance therapy plan for lung adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically diagnosed stage III/IV Lung Adenocarcinoma;\n* Age of 18-75years; Gender Not Required;\n* Received systemic clinical examination, including chest X-ray, abdomen B ultrasound, head CT scan, radionuclide bone scan;\n* Received cisplatin chemotherapy for 4 cycles before this study, the curative effect of chemotherapy is SD or above SD (efficacy evaluation time is 21 days, if it is SD, then the longest diameter of target lesions shall not increase);\n* Adequate hematologic, renal, and hepatic function, Specific index as follows: liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10\\^9/l, ANC≥2.0×10\\^9/l platelet count ≥100×10\\^9/l, Hb≥100 g/l;\n* ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;\n* The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);\n* No history of serious drug allergy;\n* Informed consent should be obtained before treatment.\n\nExclusion Criteria:\n\n* Not histologically or cytologically diagnosed as Lung Adenocarcinoma\n* The age of \\>75 years or \\<18 years.\n* Major organ dysfunction and Serious Heart Disease (congestive heart-failure, incontrollable high-risk arrhythmia, unstable angina, alular disease, myocardial infarct and Resistant hypertension,);\n* Serious complications and investigator consider it is unsuited enrolling;\n* Pregnant or lactating women;\n* Allergic to research drug;\n* Received cisplatin chemotherapy for 4 cycles before this study, the curative effect of chemotherapy is PD'}, 'identificationModule': {'nctId': 'NCT02399566', 'briefTitle': 'Clinical Trial of Erlotinib and Pemetrexed for Maintenance Treatment in Lung Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': 'Comparative Clinical Trial of Erlotinib and Pemetrexed for Maintenance Treatment in Lung Adenocarcinoma', 'orgStudyIdInfo': {'id': 'CCTEBMTLA-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy', 'interventionNames': ['Drug: Erlotinib, Pemetrexed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator', 'description': 'followed classical chemotherapy for 4 cycles, use Pemetrexed interventional for the maintenance therapy', 'interventionNames': ['Drug: Erlotinib, Pemetrexed']}], 'interventions': [{'name': 'Erlotinib, Pemetrexed', 'type': 'DRUG', 'description': 'followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy.', 'armGroupLabels': ['Comparator', 'Experimental']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'JIANHUA CHEN, MD', 'role': 'CONTACT', 'email': 'cjh_1000@163.com', 'phone': '0086-731-89762221'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jianhua Chen', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}}