Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT00460551
Status:
TERMINATED
Last Update Posted:
2011-12-06
First Post:
2007-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C546618', 'term': 'zalutumumab'}, {'id': 'D060828', 'term': 'Induction Chemotherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012074', 'term': 'Remission Induction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'E.Westerberg@genmab.com', 'phone': '+45 7020 2728', 'title': 'Eva Järlid Westerberg PhD', 'organization': 'Genmab A/S'}, 'certainAgreement': {'otherDetails': 'The site and the PI may be required to withhold the publication for up to 90 days. Subject to a reasoned request from the sponsor, the publication may be further delayed for a period up to 6 months from the date of first submission to the sponsor.\n\nThe sponsor has the right to require deletion of any trade secret, proprietary, or confidential information supplied by the sponsor to the site or the PI. The sponsor shall not otherwise have the right to censor publications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The trial was prematurely closed. The original protocol contained Part 1A, followed by Part 1B and Part 2. The trial was terminated when 13 patients were enrolled in Part 1A. Scans for efficacy were planned for Part 1B and Part 2.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Zalutumumab 8 mg/kg', 'otherNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 241, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 22, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zalatumumab 8 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 months', 'description': 'Number of participants reporting at least one adverse event', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients reporting at least one adverse event'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival Verified by Imaging Techniques.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zalatumumab 8 mg/kg'}], 'paramType': 'NUMBER', 'timeFrame': 'Until disease progression', 'description': 'Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected. Imaging scans were not taken during part 1A. The trial was prematurely closed when 13 patients were enrolled in part 1A. Scans were planned for part 1B and 2. No patients continued to part 1B and part 2.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zalutumumab 8 mg/kg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'The trial was terminated after Period 1A. Only safety was measured.', 'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Zalutumumab 8 mg/kg'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Due to considerations regarding the appropriate therapeutic regimen for these patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-05', 'studyFirstSubmitDate': '2007-04-12', 'resultsFirstSubmitDate': '2011-09-12', 'studyFirstSubmitQcDate': '2007-04-13', 'lastUpdatePostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-28', 'studyFirstPostDateStruct': {'date': '2007-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival Verified by Imaging Techniques.', 'timeFrame': 'Until disease progression', 'description': 'Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Up to 3 months', 'description': 'Number of participants reporting at least one adverse event'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.', 'detailedDescription': 'Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NSCLC stage IIIA-IIIB\n* Performance status 0 or 1 (Zubrod or WHO Scale)\n\nExclusion Criteria:\n\n* Evidence of metastases either in a separate lobe of the lung, or extra thoracic\n* Patients with high risk of radiation pneumonitis and or compromised lung function\n* Estimated life expectancy of less than 3 months\n* Prior chemotherapy for lung cancer\n* Prior radiotherapy to the chest\n* Prior surgery with curative intent for lung cancer'}, 'identificationModule': {'nctId': 'NCT00460551', 'briefTitle': 'Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genmab'}, 'officialTitle': 'A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients', 'orgStudyIdInfo': {'id': 'GEN204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zalutumumab 8 mg/kg', 'interventionNames': ['Biological: Zalutumumab', 'Drug: Induction chemotherapy', 'Radiation: Radiotherapy']}], 'interventions': [{'name': 'Zalutumumab', 'type': 'BIOLOGICAL', 'description': '8 mg/kg', 'armGroupLabels': ['Zalutumumab 8 mg/kg']}, {'name': 'Induction chemotherapy', 'type': 'DRUG', 'description': 'Combination of cisplatin and docetaxel administered as two cycles given every three weeks', 'armGroupLabels': ['Zalutumumab 8 mg/kg']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'description': '64 Gy in 32 fractions over 6.5 weeks', 'armGroupLabels': ['Zalutumumab 8 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '97213-2967', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Portland Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHR La Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Sart-Tilman Domaine Universitaire du Sart-Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '51092', 'city': 'Reims', 'state': 'Cedex', 'country': 'France', 'facility': 'CHRU Reims, Hospital Maison Blanche', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '1004MB', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU Medisch Centrum (VUMC)', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': 'SM2 5PT', 'city': 'Sutton, Surrey', 'country': 'United Kingdom', 'facility': 'The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Steen Lisby, MD, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genmab employee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genmab', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}