Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-06-07 @ 2:42 PM
Study NCT ID:
NCT02845856
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2016-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Cetuximab and NK Immunotherapy for Recurrent 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'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relief degree evaluated by RECIST', 'timeFrame': '3 months', 'description': 'It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)'}], 'secondaryOutcomes': [{'measure': 'Progress free survival (PFS)', 'timeFrame': '1 year'}, {'measure': 'Overall survival (OS)', 'timeFrame': '3 years'}]}, 'conditionsModule': {'keywords': ['recurrent lung cancer', 'EGFR mutation', 'Cetuximab', 'NK immunotherapy'], 'conditions': ['Recurrent Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is the safety and efficacy of Cetuximab plus natural killer(NK) immunotherapy to recurrent non-small cell lung cancer with EGFR mutation.', 'detailedDescription': 'By enrolling patients with lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Cetuximab and NK cells.\n\nThe safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence\n* Body tumor 1-6, the maximum tumor length \\< 5 cm\n* KPS ≥ 70, lifespan \\> 6 months\n* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L\n\nExclusion Criteria:\n\n* Patients with cardiac pacemaker\n* Patients with brain metastasis\n* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction'}, 'identificationModule': {'nctId': 'NCT02845856', 'briefTitle': 'Combination of Cetuximab and NK Immunotherapy for Recurrent Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'orgStudyIdInfo': {'id': 'NK-Cetuximab'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cetuximab and NK immunotherapy', 'description': 'In this group, the patients who have EGFR mutation of lung cancer will receive regular Cetuximab treatment accompanied with multiple NK immunotherapy. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).', 'interventionNames': ['Drug: Cetuximab', 'Biological: NK immunotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cetuximab', 'description': 'In this group, the patients who have EGFR mutation of lung cancer will receive regular Cetuximab to decrease tumor burden. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).', 'interventionNames': ['Drug: Cetuximab']}], 'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'otherNames': ['Erbitux, C225'], 'description': '400 mg/m2 IV over 120 minutes on day 1 of cycle 1 only, and 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations', 'armGroupLabels': ['Cetuximab', 'Cetuximab and NK immunotherapy']}, {'name': 'NK immunotherapy', 'type': 'BIOLOGICAL', 'description': 'For each procedure, 10 billion cells will be infused in 4 times', 'armGroupLabels': ['Cetuximab and NK immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Fuda cancer institute in Fuda cancer hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Jibing Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fuda Cancer Hospital, Guangzhou'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuda Cancer Hospital, Guangzhou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shenzhen Hank Bioengineering Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}