Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT01998061
Status:
UNKNOWN
Last Update Posted:
2013-12-20
First Post:
2013-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuation of TKI With or Without Chemotherapy Beyond Gradual Progression
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': 'C561722', 'term': 'EGFR tyrosine kinase inhibitor 324674'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-19', 'studyFirstSubmitDate': '2013-11-24', 'studyFirstSubmitQcDate': '2013-11-24', 'lastUpdatePostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'up to 24 months'}], 'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'up to 18 months'}], 'secondaryOutcomes': [{'measure': 'Objective response rate cacy', 'timeFrame': 'up to 18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'There have been reports suggesting that continuous administration of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) is advantageous for patients in which gradual disease progression was observed after the establishment of clinical benefit from EGFR-TKIs. However, whether EGFR TKI with or without chemotherapy provides more survival benefit has not been formally evaluated.', 'detailedDescription': 'We design this clinical trial to compare the efficacy of continuation of EGFR TKI with or without chemotherapy in patients beyond gradual progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nPatient who was confirmed stage IV NSCLC by pathologic histology or cytology. Males or females aged ≥18 years, \\< 75 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks.\n\nMales and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.\n\nDefinition of gradual progression:\n\n1. Slow PD (6 months of partial response/stable disease),\n2. Asymptomatic minimal PD,\n3. New brain metastasis controlled locally. Patients with asymptomatic, treated brain metastases are eligible for trial participation.\n\nAdequate bone marrow, renal, and liver function are required. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.\n\nInstitutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.\n\nExclusion criteria： Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).\n\nLack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.\n\nFemale subjects should not be pregnant or breast-feeding. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.\n\nAdequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function :Total bilirubin £ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT )and Aspartate Aminotransferase (AST )\\< 2.5 x ULN in the absence of liver metastases, or \\< 5 x ULN in case of liver metastases.\n\nPatient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.'}, 'identificationModule': {'nctId': 'NCT01998061', 'briefTitle': 'Continuation of TKI With or Without Chemotherapy Beyond Gradual Progression', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Phase II Study of Continuation of Tyrosine Kinase Inhibitor (TKI) With or Without Chemotherapy Beyond Gradual Progression in Advanced Non-small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'ZhejiangU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'TKI alone until rapid progression', 'interventionNames': ['Drug: EGFR tyrosine kinase inhibitor']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': "TKI combined with investigator's choice of chemotherapy regimen and subsequent line of treatment until rapid progression.", 'interventionNames': ['Drug: EGFR tyrosine kinase inhibitor with chemotherapy']}], 'interventions': [{'name': 'EGFR tyrosine kinase inhibitor', 'type': 'DRUG', 'otherNames': ['EGFR TKI'], 'description': 'Arm A', 'armGroupLabels': ['Arm A']}, {'name': 'EGFR tyrosine kinase inhibitor with chemotherapy', 'type': 'DRUG', 'otherNames': ['EGFR TKI with chemotherapy'], 'description': 'Arm B', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiong Zhao, PhD', 'role': 'CONTACT', 'email': 'doczq.2008@gmail.com', 'phone': '0571-87236802'}], 'facility': 'Qiong Zhao', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Department of Thoracic Oncology', 'investigatorFullName': 'Qiong Zhao', 'investigatorAffiliation': 'Zhejiang University'}}}}