Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-04-11 @ 10:02 AM
Study NCT ID:
NCT01481259
Status:
UNKNOWN
Last Update Posted:
2012-07-03
First Post:
2011-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer
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': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-02', 'studyFirstSubmitDate': '2011-11-16', 'studyFirstSubmitQcDate': '2011-11-23', 'lastUpdatePostDateStruct': {'date': '2012-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Two years'}, {'measure': 'Toxicities', 'timeFrame': 'Two years'}, {'measure': 'Quality-of-life', 'timeFrame': 'Two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nonsquamous non-small cell lung cancer', 'Maintenance therapy', 'Immunotherapy', 'Autologous cytokine-induced killer cell', 'Pemetrexed'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': "Maintenance therapy has been considered as an important component to prolong survival in patients with advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC). Previous studies have confirmed that pemetrexed is one of the effective drugs in improving progression-free survival for stage IIIb-IV nonsquamous non-small cell lung cancer. With the periodic deliveries of pemetrexed, however,the functioning status and immune system may get worse, which subsequently has an negative impact on patient's quality-of-life. Immunotherapy with autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism through stimulating immune response and altering the interaction between tumor and its host. This effect may result in improved tumor control and survival, as well as a better quality of life. To test the hypothesis, a randomised controlled study was conducted to compare CIK cells with pemetrexed as maintenance therapy for stage IIIb-IV nonsquamous non-small cell lung cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically proven nonsquamous non-small cell lung cancer\n* Stage IIIb-IV, according to AJCC 2010 Staging System\n* Disease measurable\n* Patients are currently receiving two-drug chemotherapy regimen containing a platinum-based drug as first-line therapy\n* No chemotherapy or radiotherapy prior to first-line therapy\n* Age between 18-75\n* Performance status \\<2\n* No congestive heart failure, severe arrhythmia,and coronal atherosclerosis heart disease\n* No uncontrolled metabolic disease, infection, and neurological disorders\n* No other malignancies\n* Signed study-specific consent form prior to study entry\n\nExclusion Criteria:\n\n* Patients are currently receiving radiotherapy or any chemotherapy regimen other than two-drug containing a platinum-based drug as first-line therapy\n* Pregnant or lactating women\n* Patient having hepatitis B virus infection, active tuberculosis, or other infectious diseases'}, 'identificationModule': {'nctId': 'NCT01481259', 'briefTitle': 'Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': "People's Hospital of Guangxi Zhuang Autonomous Region"}, 'officialTitle': 'Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CIKLC-201004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immunotherapy', 'description': 'Subjects receive autologous cytokine-induced killer cell infusion every 21 days', 'interventionNames': ['Biological: Autologous cytokine-induced killer cell']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pemetrexed', 'description': 'Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days', 'interventionNames': ['Other: Pemetrexed']}], 'interventions': [{'name': 'Autologous cytokine-induced killer cell', 'type': 'BIOLOGICAL', 'description': 'Subjects receive autologous cytokine-induced killer cell infusion every 21 days in the absence of disease progression or unacceptable toxicity.', 'armGroupLabels': ['Immunotherapy']}, {'name': 'Pemetrexed', 'type': 'OTHER', 'description': 'Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity.', 'armGroupLabels': ['Pemetrexed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'facility': "Clinical Cancer Center, People's Hospital of Guangxi Zhuang Autonomous Region", 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}], 'centralContacts': [{'name': 'Heming Lu, M.D', 'role': 'CONTACT', 'email': 'luhming3632@163.com', 'phone': '86-771-218-6503'}], 'overallOfficials': [{'name': 'Guosheng Feng, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "People's Hospital of Guangxi Zhuang Autonomous Region"}, {'name': 'Hui Lin, M.D', 'role': 'STUDY_CHAIR', 'affiliation': "People's Hospital of Guangxi Zhuang Autonomous Region"}, {'name': 'Yuan Liang, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Guangxi Department of Public Health'}, {'name': 'Heming Lu, M.D', 'role': 'STUDY_CHAIR', 'affiliation': "People's Hospital of Guangxi Zhuang Autonomous Region"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "People's Hospital of Guangxi Zhuang Autonomous Region", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Guosheng Feng', 'investigatorAffiliation': "People's Hospital of Guangxi Zhuang Autonomous Region"}}}}