Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-27 @ 10:16 PM
Study NCT ID:
NCT01918761
Status:
TERMINATED
Last Update Posted:
2019-12-30
First Post:
2013-05-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dacomitinib + Pemetrexed for Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)
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': 'C525726', 'term': 'dacomitinib'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'office@cecog.at', 'phone': '+43 1 409 77 25', 'title': 'MD Christiane Thallinger', 'organization': 'Cecog'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Dacomitinib, Pemetrexed', 'description': 'Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)\n\nDacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 3, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Burning mouth syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 11, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Symmetrical drug-related intertriginous and flexural exanthema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'General physical condition abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Weight loss poor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nail bed inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Scrotal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'General physical condition abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dacomitinib, Pemetrexed', 'description': 'Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)\n\nDacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '85.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to end of treatment or death, whichever occurs first. The study was suspended after 36 months.', 'description': 'The primary objective of this study is to determine the maximal tolerated dose (MTD) of the combination pemetrexed + dacomitinib by the incidence of dose limiting toxicities (DLTs).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dacomitinib, Pemetrexed', 'description': 'Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)\n\nDacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '52.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until progression of disease (PD) or 24 month after end of treatment for participants with no PD. The study was suspended after 36 months', 'description': 'Overall Response Rate (ORR) is defined as the proportion of patients with complete Response (CR) or partial Response (PR).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dacomitinib, Pemetrexed', 'description': 'Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)\n\nDacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'comment': 'The upper confidence interval was not reached due to an insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'until date of death. The study was suspended after 36 months.', 'description': 'Overall survival (OS) defined as time from start of Dacomitinib to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. Patients were followed up for survival for 24 month after end of Treatment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dacomitinib, Pemetrexed', 'description': 'Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)\n\nDacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'comment': 'The upper confidence interval was not reached due to an insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to progression or death due to any cause. The study was suspended after 36 months', 'description': 'Progression-free survival (PFS) defined as time from start of Dacomitinib to date of progression or date of death from any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients were followed up for progression-free survival for 24 month after end of Treatment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dacomitinib, Pemetrexed', 'description': 'Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)\n\nDacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dacomitinib, Pemetrexed', 'description': 'Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)\n\nDacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'spread': '11.14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/ Caucasian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) performance status', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '1', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '0 - Asymptomatic, 1 - Symptomatic but completely ambulatory, 2 - Symptomatic, \\<50% in bed during the day, 3 - Symptomatic, \\>50% in bed, but not bedbound, 4 - Bedbound, 5 - Death', 'unitOfMeasure': 'Participants'}, {'title': 'KRAS status', 'classes': [{'categories': [{'title': 'Negative', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not determined', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Epidermal growth factor receptor (EGFR) mutation status', 'classes': [{'categories': [{'title': 'Negative', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not determined', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'spread': '9.68', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart rate', 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'spread': '8.62', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'bpm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '176.4', 'spread': '14.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Temperature', 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'groupId': 'BG000', 'lowerLimit': '36.0', 'upperLimit': '36.8'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '°C', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body Surface Area (BSA)', 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.20', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stage at primary diagnosis: Primary tumor (T)', 'classes': [{'categories': [{'title': 'T0', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'T1b', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'T2a', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'T4', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Tis - Carcinoma in situ, Tx - Primary Tumor cannot be assessed, T1b - Tumor \\> 10 mm but ≤ 20 mm in greatest dimension, T2a - Tumor \\> 30 mm but ≤ 40 mm in greatest dimension, T3 - Tumor \\> 50 mm but ≤ 70 mm in greatest dimension or tumor of any size with direct extension to chest wall, pericadium, phrenic nerve or satellite nodules in the same lobe, T4 - Tumor \\> 70 mm or any tumor with Invasion of mediastinum, diaphragm, heart, great vessels, recurrent laryngeal nerve, carina, trachea, oesophagus, spine or separate tumor in different lobe of ipsilateral lung', 'unitOfMeasure': 'Participants'}, {'title': 'Stage at primary diagnosis: Regional lymph nodes (N)', 'classes': [{'categories': [{'title': 'N0', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'N2', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'N3', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Nx - Regional lymph nodes cannot be assessed, N0 - No regional lymph node metastases, N1 - Metastasis to ipsilateral peribronchial and/or hilar lymph nodes, N2 - Metastasis to ipsilateral mediastinal and/or subcarinal lymph nodes, N3 - Metastasis to scalene or supraclavicular lymph nodes, metastasis to contralateral hilar or mediastinal lymph nodes', 'unitOfMeasure': 'Participants'}, {'title': 'Stage at primary diagnosis: Distant metastasis (M)', 'classes': [{'categories': [{'title': 'M0', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'M1', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'M0 - No clinical or radiographic evidence of distant metastases, M1 - Distant metastases detected, Mx - Metastases cannot be assessed.', 'unitOfMeasure': 'Participants'}, {'title': 'Prior chemotherapy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior surgery', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior radiotherapy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior antibody therapy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Electrocardiogram (ECG) results', 'classes': [{'categories': [{'title': 'Abnormal', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Normal', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Left Ventricular Ejection Fraction (LVEF)', 'classes': [{'categories': [{'measurements': [{'value': '65.2', 'spread': '12.28', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-07-30'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-12', 'studyFirstSubmitDate': '2013-05-27', 'resultsFirstSubmitDate': '2019-11-21', 'studyFirstSubmitQcDate': '2013-08-07', 'lastUpdatePostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-12', 'studyFirstPostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicities (DLTs)', 'timeFrame': 'From start of treatment to end of treatment or death, whichever occurs first. The study was suspended after 36 months.', 'description': 'The primary objective of this study is to determine the maximal tolerated dose (MTD) of the combination pemetrexed + dacomitinib by the incidence of dose limiting toxicities (DLTs).'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate', 'timeFrame': 'Until progression of disease (PD) or 24 month after end of treatment for participants with no PD. The study was suspended after 36 months', 'description': 'Overall Response Rate (ORR) is defined as the proportion of patients with complete Response (CR) or partial Response (PR).'}, {'measure': 'Overall Survival', 'timeFrame': 'until date of death. The study was suspended after 36 months.', 'description': 'Overall survival (OS) defined as time from start of Dacomitinib to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. Patients were followed up for survival for 24 month after end of Treatment.'}, {'measure': 'Progression-free Survival', 'timeFrame': 'Up to progression or death due to any cause. The study was suspended after 36 months', 'description': 'Progression-free survival (PFS) defined as time from start of Dacomitinib to date of progression or date of death from any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients were followed up for progression-free survival for 24 month after end of Treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NSCLC', 'Stage IV', 'Pemetrexed', 'Dacomitinib'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'To identify a dose of dacomitinib in combination with pemetrexed that is safe and tolerated as determined by the incidence of DLTs (dose limiting toxicities).', 'detailedDescription': 'This open label phase Ib trial aims to determine the safety, tolerability, the pharmacokinetic profile, and to identify a dose of dacomitinib in combination with pemetrexed.\n\nThree sites in Austria will participate in this study. Six to nine patients will initially be enrolled to receive the target dose of 45 mg qd dacomitinib (starting from day 2 of first cycle) in combination with pemetrexed (500 mg/m² 10 min infusion, once every 3 weeks). One cycle is defined as 21 days.\n\nThe first 3 subjects will be enrolled at a rate of ≤ 1 subject per week. If the target dose regimen is safe based on the incidence of DLT another 3 subjects will be enrolled.\n\nIf the dose of 45 mg qd is not safe alternate lower doses will be explored (dose level -1, dose level -2) to identify the maximal tolerated dose (MTD) of dacomitinib in combination of pemetrexed. Six to nine patients per dose level will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Written informed consent\n* Histologically or cytologically confirmed stage IV non-squamous NSCLC\n* Patients who are candidates to receive pemetrexed monotherapy\n* If pemetrexed has been administered as first line therapy there must be a treatment free interval of at least one cycle (21 days)\n* Measurable disease by RECIST criteria version 1.1.\n* ≥18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* Adequate left ventricular ejection fraction (LVEF) ≥ 50% by either echocardiogram or multigated acquisition scan (MUGA)\n* Adequate organ function, including:\n\n 1. Adequate bone marrow reserve: absolute neutrophil count (ANC) should be ≥ 1500 cells/mm3, platelets should be ≥ 100.000 cells/mm3\n 2. Creatinine clearance ≥ 45 mL/min\n 3. Total bilirubin ≤ 1.5 x upper normal limit (ULN)\n 4. Aspartate Aminotransferase (AST) (SGOT) ≤ 3 x ULN (≤ 5.0 x ULN if hepatic metastases)\n 5. Alanine Aminotransferase (ALT) (SGPT) ≤ 3 x ULN (≤ 5.0 x ULN if hepatic metastases)\n* Female patients or their partners must be postmenopausal (defined as 12 months of amenorrhea following last menses), surgically sterile or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter (the definition of effective contraception will be based on the judgment of the investigator). Male patients or their partners must be surgically sterile or must agree to use a barrier method of contraception while receiving trial treatment and for at least 3 months thereafter. (In all cases the definition of effective contraception will be based on the judgment of the investigator).\n* Able to comply with required protocol procedures and able to receive oral medications\n\nExclusion criteria:\n\n* Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer\n* Predominantly squamous cell histology\n* Patients with symptomatic brain metastases\n* Chemotherapy, radiotherapy, biological or investigational agents within two weeks of baseline disease assessments\n* Patients with uncontrolled or significant cardiovascular disease, including:\n\n 1. Myocardial infarction within 12 months\n 2. Uncontrolled angina within 6 months\n 3. Congestive heart failure within 6 months\n 4. Diagnosed or suspected congenital long QT syndrome\n 5. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)\n 6. Prolonged QTc interval on pre-entry electrocardiogram. QTc must be less than CTC Grade 2 (≤480 msec) using appropriate correction formula with manual read by investigator if required. The echocardiogram (ECG) may be repeated for evaluation of eligibility after management of correctable causes for observed QTc prolongation\n 7. Any history of second or third degree heart block (may be eligible if currently have a pacemaker)\n 8. Heart rate \\<50/minute on baseline electrocardiogram\n 9. Uncontrolled hypertension\n* Prior malignancy: Patients will not be eligible if they have evidence of other malignancy (other than non-melanoma skin cancer or in situ cervical cancer, or localized and presumed cured prostate cancer with prostate specific antigen (PSA) \\< ULN) within the last 3 years.\n* Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start. Known hypersensitivity to pemetrexed and/or dacomitinib\n* Patients with exposure to other investigational drug therapy\n* Previous therapy with an oral tyrosine kinase inhibitor (TKI)'}, 'identificationModule': {'nctId': 'NCT01918761', 'briefTitle': 'Dacomitinib + Pemetrexed for Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'OTHER', 'fullName': 'Central European Cooperative Oncology Group'}, 'officialTitle': 'Dacomitinib + Pemetrexed for Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC): a Phase I Trial to Identify a Dose of Dacomitinib in Combination With Pemetrexed That is Safe and Tolerated as Determined by the Incidence of Dose Limiting Toxicities (DLTs)', 'orgStudyIdInfo': {'id': 'CECOG/ NSCLC.1.1.001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dacomitinib, Pemetrexed', 'description': 'Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)', 'interventionNames': ['Drug: Dacomitinib, Pemetrexed']}], 'interventions': [{'name': 'Dacomitinib, Pemetrexed', 'type': 'DRUG', 'otherNames': ['Alimta'], 'description': 'Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)', 'armGroupLabels': ['Dacomitinib, Pemetrexed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Medizinische Universität Graz Klinische Abteilung für Onkologie', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Universitätsklinik für Innere Medizin I', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Christoph C Zielinski, Univ. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univ Clinic for Internal Medicine I, Dep of Oncology, Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central European Cooperative Oncology Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}