Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-02-22 @ 2:45 PM
Study NCT ID:
NCT01802632
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2013-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AZD9291 First Time In Patients Ascending Dose Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596361', 'term': 'osimertinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Senior Medical Director, Tagrisso', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review, should the submission for publication be delayed in order to file patent application. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'All 6 cohorts are still on-going. Data cut-off on 1st May 2015 was for primary analyses in main cohorts of dose escalation, dose expansion, extension. AEs presented for all cohorts.'}}, 'adverseEventsModule': {'timeFrame': 'AEs from start of study drug until 28 days post study treatment discontinuation, up to approximately 25 months (at time of analysis).', 'description': 'Different cohorts started at different times and so some cohorts have collected AE data for a shorter length of time, e.g. Extension cohort was the last cohort and follow up is approximately 12 months at time of analysis. Systematic assessment due to regular investigator assessment at study visits.', 'eventGroups': [{'id': 'EG000', 'title': 'AZD9291 80mg Extension', 'description': 'Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.', 'otherNumAtRisk': 201, 'otherNumAffected': 191, 'seriousNumAtRisk': 201, 'seriousNumAffected': 41}, {'id': 'EG001', 'title': 'Dose Escalation', 'description': 'Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.', 'otherNumAtRisk': 31, 'otherNumAffected': 31, 'seriousNumAtRisk': 31, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Dose Expansion', 'description': 'Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.', 'otherNumAtRisk': 271, 'otherNumAffected': 265, 'seriousNumAtRisk': 271, 'seriousNumAffected': 78}, {'id': 'EG003', 'title': 'First Line', 'description': 'Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.', 'otherNumAtRisk': 60, 'otherNumAffected': 60, 'seriousNumAtRisk': 60, 'seriousNumAffected': 14}, {'id': 'EG004', 'title': '80mg Tablet', 'description': 'US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).', 'otherNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Japan Cytology', 'description': 'Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.', 'otherNumAtRisk': 28, 'otherNumAffected': 24, 'seriousNumAtRisk': 28, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': 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'EG005', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 31, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 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18.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 45, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 96, 'numAffected': 72}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 63, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 36, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 31, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 73, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 34, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 36, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 68, 'numAffected': 64}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 4, 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'MedDRA 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 15, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 10, 'numAffected': 6}, 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{'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 20, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 17, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 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[{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 34, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 36, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 271, 'numEvents': 64, 'numAffected': 55}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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ORR is the percentage of patients with at least 1 visit response of CR or PR (by independent central review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.', 'unitOfMeasure': '% of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by independent central review) at baseline.'}, {'type': 'SECONDARY', 'title': 'Best Objective Response (BOR) for 80mg AZD9291 Extension Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '80mg AZD9291 Extension', 'description': 'Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '54.1', 'upperLimit': '68.9'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '70.1', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}]}]}, {'title': 'Not evaluable', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)', 'description': 'Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \\>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \\>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by investigator assessment) at baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD9291 80mg Extension', 'description': 'Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.'}, {'id': 'FG001', 'title': 'Dose Escalation', 'description': 'Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.'}, {'id': 'FG002', 'title': 'Dose Expansion', 'description': 'Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.'}, {'id': 'FG003', 'title': 'First Line', 'description': 'Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.'}, {'id': 'FG004', 'title': '80mg Tablet', 'description': 'US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).'}, {'id': 'FG005', 'title': 'Japan Cytology', 'description': 'Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '271'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '271'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Objective Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Ongoing Study at Data Cut-off', 'reasons': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '115'}, {'groupId': 'FG003', 'numSubjects': '50'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '22'}]}, {'type': 'Other (not specified)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients recruited to different cohorts. Dose escalation cohort of pre-treated patients in 5 dose groups. Dose expansion cohort (pre-treated) in same 5 dose groups. First line patient cohort. 80mg tablet cohort of pre-treated patients. Japan-only cohort (EGFR T790M+ by cytology). Phase II extension cohort in pre-treated EGFR T790M+ patients.', 'preAssignmentDetails': '603 patients were enrolled and received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '603', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD9291 80mg Extension', 'description': 'Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.'}, {'id': 'BG001', 'title': 'Dose Escalation', 'description': 'Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.'}, {'id': 'BG002', 'title': 'Dose Expansion', 'description': 'Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.'}, {'id': 'BG003', 'title': 'First Line', 'description': 'Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.'}, {'id': 'BG004', 'title': '80mg Tablet', 'description': 'US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).'}, {'id': 'BG005', 'title': 'Japan Cytology', 'description': 'Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<50 Years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '89', 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'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '394', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '209', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '370', 'groupId': 'BG006'}]}]}, {'title': 'Black Or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '197', 'groupId': 'BG006'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 603}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2013-02-25', 'resultsFirstSubmitDate': '2016-04-29', 'studyFirstSubmitQcDate': '2013-02-28', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-12', 'studyFirstPostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) for Dose Expansion Population', 'timeFrame': 'RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)', 'description': 'Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by investigator assessment) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.'}, {'measure': 'Best Objective Response (BOR) for Dose Escalation Population', 'timeFrame': 'RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)', 'description': 'Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \\>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \\>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.'}, {'measure': 'Objective Response Rate (ORR) for Extension Population', 'timeFrame': 'RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)', 'description': 'Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by independent central review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DoR) for Dose Expansion Population', 'timeFrame': 'RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)', 'description': 'Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).'}, {'measure': 'Progression-Free Survival (PFS) for Dose Expansion Population', 'timeFrame': 'RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)', 'description': 'Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \\>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \\>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent central review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.'}, {'measure': 'Best Objective Response (BOR) for 80mg AZD9291 Extension Population', 'timeFrame': 'RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)', 'description': 'Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \\>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \\>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oncology,', 'Non Small Cell Lung Cancer,', 'Metastatic,', 'EGFR sensitivity mutation,', 'T790M resistance mutation'], 'conditions': ['Advanced Non Small Cell Lung Cancer', 'Advanced (Inoperable) Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '40311309', 'type': 'DERIVED', 'citation': 'Murat-Onana ML, Ramalingam SS, Janne PA, Gray JE, Ahn MJ, John T, Yatabe Y, Huang X, Rukazenkov Y, Javey M, Brown H, Li-Sucholeiki X. EGFR mutation testing across the osimertinib clinical program. Lung Cancer. 2025 Jun;204:108549. doi: 10.1016/j.lungcan.2025.108549. Epub 2025 Apr 18.'}, {'pmid': '34056687', 'type': 'DERIVED', 'citation': 'Martin ML, Correll J, Walding A, Ryden A. How patients being treated for non-small cell lung cancer value treatment benefit despite side effects. Qual Life Res. 2022 Jan;31(1):135-146. doi: 10.1007/s11136-021-02882-6. Epub 2021 May 31.'}, {'pmid': '31345012', 'type': 'DERIVED', 'citation': 'Ahn MJ, Han JY, Kim DW, Cho BC, Kang JH, Kim SW, Yang JC, Mitsudomi T, Lee JS. Osimertinib in Patients with T790M-Positive Advanced Non-small Cell Lung Cancer: Korean Subgroup Analysis from Phase II Studies. Cancer Res Treat. 2020 Jan;52(1):284-291. doi: 10.4143/crt.2019.200. Epub 2019 Jul 23.'}, {'pmid': '30512189', 'type': 'DERIVED', 'citation': 'Ahn MJ, Tsai CM, Shepherd FA, Bazhenova L, Sequist LV, Hida T, Yang JCH, Ramalingam SS, Mitsudomi T, Janne PA, Mann H, Cantarini M, Goss G. Osimertinib in patients with T790M mutation-positive, advanced non-small cell lung cancer: Long-term follow-up from a pooled analysis of 2 phase 2 studies. Cancer. 2019 Mar 15;125(6):892-901. doi: 10.1002/cncr.31891. Epub 2018 Dec 4.'}, {'pmid': '30073261', 'type': 'DERIVED', 'citation': 'Oxnard GR, Hu Y, Mileham KF, Husain H, Costa DB, Tracy P, Feeney N, Sholl LM, Dahlberg SE, Redig AJ, Kwiatkowski DJ, Rabin MS, Paweletz CP, Thress KS, Janne PA. Assessment of Resistance Mechanisms and Clinical Implications in Patients With EGFR T790M-Positive Lung Cancer and Acquired Resistance to Osimertinib. JAMA Oncol. 2018 Nov 1;4(11):1527-1534. doi: 10.1001/jamaoncol.2018.2969.'}, {'pmid': '29363250', 'type': 'DERIVED', 'citation': 'Kiura K, Yoh K, Katakami N, Nogami N, Kasahara K, Takahashi T, Okamoto I, Cantarini M, Hodge R, Uchida H. Osimertinib in patients with epidermal growth factor receptor T790M advanced non-small cell lung cancer selected using cytology samples. Cancer Sci. 2018 Apr;109(4):1177-1184. doi: 10.1111/cas.13511. Epub 2018 Feb 27.'}, {'pmid': '29293889', 'type': 'DERIVED', 'citation': 'Goss G, Tsai CM, Shepherd FA, Ahn MJ, Bazhenova L, Crino L, de Marinis F, Felip E, Morabito A, Hodge R, Cantarini M, Johnson M, Mitsudomi T, Janne PA, Yang JC. CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from two phase II trials. Ann Oncol. 2018 Mar 1;29(3):687-693. doi: 10.1093/annonc/mdx820.'}, {'pmid': '28841389', 'type': 'DERIVED', 'citation': 'Ramalingam SS, Yang JC, Lee CK, Kurata T, Kim DW, John T, Nogami N, Ohe Y, Mann H, Rukazenkov Y, Ghiorghiu S, Stetson D, Markovets A, Barrett JC, Thress KS, Janne PA. Osimertinib As First-Line Treatment of EGFR Mutation-Positive Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Mar 20;36(9):841-849. doi: 10.1200/JCO.2017.74.7576. Epub 2017 Aug 25.'}, {'pmid': '28751247', 'type': 'DERIVED', 'citation': 'Thress KS, Jacobs V, Angell HK, Yang JC, Sequist LV, Blackhall F, Su WC, Schuler M, Wolf J, Gold KA, Cantarini M, Barrett JC, Janne PA. Modulation of Biomarker Expression by Osimertinib: Results of the Paired Tumor Biopsy Cohorts of the AURA Phase I Trial. J Thorac Oncol. 2017 Oct;12(10):1588-1594. doi: 10.1016/j.jtho.2017.07.011. Epub 2017 Jul 24.'}, {'pmid': '28577957', 'type': 'DERIVED', 'citation': 'Dearden S, Brown H, Jenkins S, Thress KS, Cantarini M, Cole R, Ranson M, Janne PA. EGFR T790M mutation testing within the osimertinib AURA Phase I study. Lung Cancer. 2017 Jul;109:9-13. doi: 10.1016/j.lungcan.2017.04.011. Epub 2017 Apr 19.'}, {'pmid': '27435396', 'type': 'DERIVED', 'citation': 'Ballard P, Yates JW, Yang Z, Kim DW, Yang JC, Cantarini M, Pickup K, Jordan A, Hickey M, Grist M, Box M, Johnstrom P, Varnas K, Malmquist J, Thress KS, Janne PA, Cross D. Preclinical Comparison of Osimertinib with Other EGFR-TKIs in EGFR-Mutant NSCLC Brain Metastases Models, and Early Evidence of Clinical Brain Metastases Activity. Clin Cancer Res. 2016 Oct 15;22(20):5130-5140. doi: 10.1158/1078-0432.CCR-16-0399. Epub 2016 Jul 19.'}, {'pmid': '27354477', 'type': 'DERIVED', 'citation': 'Oxnard GR, Thress KS, Alden RS, Lawrance R, Paweletz CP, Cantarini M, Yang JC, Barrett JC, Janne PA. Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Oct 1;34(28):3375-82. doi: 10.1200/JCO.2016.66.7162. Epub 2016 Jun 27.'}, {'pmid': '26494259', 'type': 'DERIVED', 'citation': 'Thress KS, Brant R, Carr TH, Dearden S, Jenkins S, Brown H, Hammett T, Cantarini M, Barrett JC. EGFR mutation detection in ctDNA from NSCLC patient plasma: A cross-platform comparison of leading technologies to support the clinical development of AZD9291. Lung Cancer. 2015 Dec;90(3):509-15. doi: 10.1016/j.lungcan.2015.10.004. Epub 2015 Oct 9.'}, {'pmid': '26473643', 'type': 'DERIVED', 'citation': 'Kim TM, Song A, Kim DW, Kim S, Ahn YO, Keam B, Jeon YK, Lee SH, Chung DH, Heo DS. Mechanisms of Acquired Resistance to AZD9291: A Mutation-Selective, Irreversible EGFR Inhibitor. J Thorac Oncol. 2015 Dec;10(12):1736-44. doi: 10.1097/JTO.0000000000000688.'}, {'pmid': '26181354', 'type': 'DERIVED', 'citation': 'Yu HA, Tian SK, Drilon AE, Borsu L, Riely GJ, Arcila ME, Ladanyi M. Acquired Resistance of EGFR-Mutant Lung Cancer to a T790M-Specific EGFR Inhibitor: Emergence of a Third Mutation (C797S) in the EGFR Tyrosine Kinase Domain. JAMA Oncol. 2015 Oct;1(7):982-4. doi: 10.1001/jamaoncol.2015.1066. No abstract available.'}, {'pmid': '25923549', 'type': 'DERIVED', 'citation': 'Janne PA, Yang JC, Kim DW, Planchard D, Ohe Y, Ramalingam SS, Ahn MJ, Kim SW, Su WC, Horn L, Haggstrom D, Felip E, Kim JH, Frewer P, Cantarini M, Brown KH, Dickinson PA, Ghiorghiu S, Ranson M. AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer. N Engl J Med. 2015 Apr 30;372(18):1689-99. doi: 10.1056/NEJMoa1411817.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=492&filename=D5160C00001AURA_Protocol_for_AZ_ClinTrials_Website.pdf', 'label': 'D5160C00001AURA\\_Protocol\\_for\\_AZ\\_ClinTrials\\_Website'}]}, 'descriptionModule': {'briefSummary': 'This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.', 'detailedDescription': 'A Phase I/II, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Ascending Doses of AZD9291 in Patients with Advanced Non Small Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent (AURA)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses\n* Aged at least 18 years. Patients from Japan aged at least 20 years.\n* Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC).\n* Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g. gefitinib or erlotinib (with the exception of 1st line expansion cohort). In addition other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.\n* Patients (with the exception of 1st line expansion cohort) must fulfil one of the following:\n\n * Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) OR\n * Must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria (Jackman et al 2010) followed by systemic objective progression (RECIST or WHO) while on continuous treatment with EGFR TKI.\n* Previous treatment with a single-agent EGFR TKI (e.g. gefitinib or erlotinib).\n* Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing or evidence of non-child bearing potential.\n* Male patients should be willing to use barrier contraception.\n* For 1st Line expansion cohort ONLY, confirmation that the tumour is EGFRm+ve and have had no prior therapy for their advanced disease (for 1st line patients biopsy will be at time of diagnosis of advanced disease).\n* For dose expansion and extension cohorts, patients must also have confirmation of tumour T790M mutation status (confirmed positive or negative) from a biopsy sample taken after disease progression on the most recent treatment regimen (irrespective of whether this is EGFR TKI or chemotherapy).\n\nPrior to entry a result from the central analysis of the patient's T790M mutation status must be obtained.\n\n\\- World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.\n\nExclusion Criteria:\n\n* Treatment with an EGFR TKI (erlotinib or gefitinib) within 8 days (approximately 5x half-life) of the first dose of study treatment.\n* Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.\n* AZD9291 in the present study (ie, dosing with AZD9291 previously initiated in this study).\n* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection.\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease."}, 'identificationModule': {'nctId': 'NCT01802632', 'acronym': 'AURA', 'briefTitle': 'AZD9291 First Time In Patients Ascending Dose Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AZD9291 in Patients With Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent', 'orgStudyIdInfo': {'id': 'D5160C00001'}, 'secondaryIdInfos': [{'id': '2012-004628-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daily dose of AZD9291', 'description': 'Daily oral dose of AZD9291', 'interventionNames': ['Drug: AZD9291']}], 'interventions': [{'name': 'AZD9291', 'type': 'DRUG', 'description': 'Starting dose 20 mg, administered once daily. 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