Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT04619004
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-20
First Post:
2020-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000710748', 'term': 'patritumab deruxtecan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTRinfo@dsi.com', 'phone': '9089926400', 'title': 'Contact for Clinical Trial Information', 'organization': 'Daiichi Sankyo, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date).', 'description': 'Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'Patritumab Deruxtecan 5.6 mg/kg', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)', 'otherNumAtRisk': 225, 'deathsNumAtRisk': 225, 'otherNumAffected': 223, 'seriousNumAtRisk': 225, 'deathsNumAffected': 114, 'seriousNumAffected': 90}, {'id': 'EG001', 'title': 'Patritumab Deruxtecan Up-Titration', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 49, 'seriousNumAtRisk': 50, 'deathsNumAffected': 28, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 215, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 48, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 95, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 91, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 21, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 70, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 79, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 70, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 23, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 16, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 88, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 22, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 104, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 32, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 85, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 20, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 56, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 39, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 15, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 27, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 115, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 28, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 49, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 107, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 23, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 59, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 35, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 57, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 44, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 40, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 27, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}], 'seriousEvents': [{'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.1'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 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up-titration regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions based on RECIST v1.1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Objective response rate was assessed in the Efficacy Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patritumab Deruxtecan 5.6 mg/kg', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)'}, {'id': 'OG001', 'title': 'Patritumab Deruxtecan Up-Titration', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen'}], 'classes': [{'title': 'Duration of response (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '7.2'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '15.2'}]}]}, {'title': 'Duration of response (Investigator)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '7.2'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '9.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'DoR is defined as the time from the first documented confirmed response (CR or PR) to the date of progression or death due to any cause as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of response rate was assessed in participants with confirmed CR or PR in the Efficacy Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patritumab Deruxtecan 5.6 mg/kg', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)'}, {'id': 'OG001', 'title': 'Patritumab Deruxtecan Up-Titration', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen'}], 'classes': [{'title': 'Progression-free survival (BICR)', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '5.9'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '8.8'}]}]}, {'title': 'Progression-free survival (Investigator)', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '5.7'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '8.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'PFS is defined as the time from the start of study treatment to the first documentation of objective progressive disease (PD) per RECIST v1.1 or death due to any cause. PFS will be determined by BICR and by Investigator, respectively.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Progression-free survival was assessed in the Efficacy Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patritumab Deruxtecan 5.6 mg/kg', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)'}, {'id': 'OG001', 'title': 'Patritumab Deruxtecan Up-Titration', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'ORR is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR as assessed by the Investigator per RECIST v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Objective response rate was assessed in the Efficacy Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patritumab Deruxtecan 5.6 mg/kg', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)'}, {'id': 'OG001', 'title': 'Patritumab Deruxtecan Up-Titration', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen'}], 'classes': [{'title': 'Disease control rate (BICR)', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Disease control rate (Investigator)', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'DCR is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD) as assessed by BICR and by the Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Disease control rate was assessed in the Efficacy Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Time to Tumor Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patritumab Deruxtecan 5.6 mg/kg', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)'}, {'id': 'OG001', 'title': 'Patritumab Deruxtecan Up-Titration', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen'}], 'classes': [{'title': 'Time to response (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Time to response (Investigator)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'TTR is defined as the time from the start of study treatment to the date of the first documentation of confirmed response (CR or PR) as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Time to response rate was assessed in participants with confirmed CR or PR in the Efficacy Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patritumab Deruxtecan 5.6 mg/kg', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)'}, {'id': 'OG001', 'title': 'Patritumab Deruxtecan Up-Titration', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen'}], 'classes': [{'title': 'Sum of diameters (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-25.66', 'spread': '30.39', 'groupId': 'OG000'}, {'value': '-17.48', 'spread': '29.54', 'groupId': 'OG001'}]}]}, {'title': 'Sum of diameters (Investigator)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.84', 'spread': '27.01', 'groupId': 'OG000'}, {'value': '-11.46', 'spread': '29.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'The best percentage change in the SoD of measurable tumors is defined as the percentage change in the smallest SoD from all post-baseline tumor assessments, taking as reference the baseline SoD.', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage change in the sum of diameters was assessed in participants with available data in the Efficacy Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'timeFrame': 'Death date is collected until the participant discontinues the study or up to approximately 45 months', 'description': 'OS defined as the time from the start of study treatment to the date of death due to any cause.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-11'}, {'type': 'SECONDARY', 'title': 'Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)', 'timeFrame': 'From baseline up to Day 47 post last dose', 'description': 'A TEAE is defined as an adverse event (AE) with a start or worsening date during the on-treatment period. A serious AE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, or may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes noted. AESIs will also be assessed. Adverse events will be coded using MedDRA and will be graded using NCI-CTCAE v5.0.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-11'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patritumab Deruxtecan 5.6 mg/kg', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)'}, {'id': 'FG001', 'title': 'Patritumab Deruxtecan Up-Titration', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received a patritumab deruxtecan up-titration regimen'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'comment': 'Ongoing patients as of data cutoff date', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Other - Not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 277 participants were enrolled and randomized to treatment at clinical sites in the United States, Japan, Republic of Korea, Singapore, Taiwan, Austria, Belgium, Bulgaria, France, Germany, Italy, Netherlands, Spain, United Kingdom, and Australia. Two participants did not receive any treatment. (1 person in each treatment arm).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Patritumab Deruxtecan 5.6 mg/kg', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)'}, {'id': 'BG001', 'title': 'Patritumab Deruxtecan Up-Titration', 'description': 'Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '9.86', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '10.07', 'groupId': 'BG001'}, {'value': '62.2', 'spread': '9.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}, {'title': '<75 years', 'categories': [{'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}, {'title': '≥75 years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}, {'title': 'Black or African-American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Demographic and baseline characteristics were reported from the Full Analysis Set.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-31', 'size': 1356123, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-04T14:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 277}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2020-10-29', 'resultsFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2020-11-05', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-04', 'studyFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)', 'timeFrame': 'Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions based on RECIST v1.1.'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DoR)', 'timeFrame': 'Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'DoR is defined as the time from the first documented confirmed response (CR or PR) to the date of progression or death due to any cause as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'PFS is defined as the time from the start of study treatment to the first documentation of objective progressive disease (PD) per RECIST v1.1 or death due to any cause. PFS will be determined by BICR and by Investigator, respectively.'}, {'measure': 'Objective Response Rate (ORR) as Assessed by the Investigator', 'timeFrame': 'Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'ORR is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR as assessed by the Investigator per RECIST v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'DCR is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD) as assessed by BICR and by the Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.'}, {'measure': 'Time to Tumor Response (TTR)', 'timeFrame': 'Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'TTR is defined as the time from the start of study treatment to the date of the first documentation of confirmed response (CR or PR) as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.'}, {'measure': 'Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors', 'timeFrame': 'Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months', 'description': 'The best percentage change in the SoD of measurable tumors is defined as the percentage change in the smallest SoD from all post-baseline tumor assessments, taking as reference the baseline SoD.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Death date is collected until the participant discontinues the study or up to approximately 45 months', 'description': 'OS defined as the time from the start of study treatment to the date of death due to any cause.'}, {'measure': 'Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)', 'timeFrame': 'From baseline up to Day 47 post last dose', 'description': 'A TEAE is defined as an adverse event (AE) with a start or worsening date during the on-treatment period. A serious AE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, or may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes noted. AESIs will also be assessed. Adverse events will be coded using MedDRA and will be graded using NCI-CTCAE v5.0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Small Cell Lung Cancer Metastatic', 'Non-Small Cell Lung Cancer with Mutation in Epidermal Growth Factor Receptor', 'Epidermal growth factor receptor', 'HER3-DXd', 'Patritumab Deruxtecan', 'U3-1402'], 'conditions': ['Non-Small Cell Lung Cancer Metastatic', 'Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor']}, 'referencesModule': {'references': [{'pmid': '37689979', 'type': 'DERIVED', 'citation': 'Yu HA, Goto Y, Hayashi H, Felip E, Chih-Hsin Yang J, Reck M, Yoh K, Lee SH, Paz-Ares L, Besse B, Bironzo P, Kim DW, Johnson ML, Wu YL, John T, Kao S, Kozuki T, Massarelli E, Patel J, Smit E, Reckamp KL, Dong Q, Shrestha P, Fan PD, Patel P, Sporchia A, Sternberg DW, Sellami D, Janne PA. HERTHENA-Lung01, a Phase II Trial of Patritumab Deruxtecan (HER3-DXd) in Epidermal Growth Factor Receptor-Mutated Non-Small-Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Platinum-Based Chemotherapy. J Clin Oncol. 2023 Dec 10;41(35):5363-5375. doi: 10.1200/JCO.23.01476. Epub 2023 Sep 10.'}, {'pmid': '37212796', 'type': 'DERIVED', 'citation': 'Yu HA, Yang JC, Hayashi H, Goto Y, Felip E, Reck M, Vigliotti M, Dong Q, Cantero F, Fan PD, Kanai M, Sternberg DW, Janne PA. HERTHENA-Lung01: a phase II study of patritumab deruxtecan (HER3-DXd) in previously treated metastatic EGFR-mutated NSCLC. Future Oncol. 2023 Jun;19(19):1319-1329. doi: 10.2217/fon-2022-1250. Epub 2023 May 22.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.', 'detailedDescription': 'This study will initially randomize participants to one of 2 arms in a 1:1 ratio to receive either a 5.6 mg/kg fixed dose regimen or an up-titration dose regimen of patritumab deruxtecan (HER3-DXd, U3-1402).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for inclusion in this study.\n\n* Sign and date the tissue informed consent form (ICF) and the main ICF, prior to the start of any study-specific qualification procedures.\n* Male or female participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n* Histologically or cytologically documented locally advanced or metastatic NSCLC not amenable to curative surgery or radiation.\n* Documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease. Participants must have received both of the following:\n\n * Prior treatment with osimertinib. Participants receiving an EGFR TKI at the time of signing informed consent should continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1. Participants in South Korea known to harbor a clinically actionable genomic alteration in addition to EGFR mutation (e.g., anaplastic lymphoma kinase \\[ALK\\] or ROS1 protocol oncogene 1 \\[ROS1\\] fusion) for which treatment is available must have also received prior treatment with at least 1 approved genotype-directed therapy, unless unable (i.e., if contraindicated). No new testing for these genomic alterations (e.g., ALK or ROS1 fusion) is required for Screening.\n * Systemic therapy with at least 1 platinum-based chemotherapy regimen.\n* Documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R.\n* At least 1 measurable lesion confirmed by BICR as per RECIST v1.1\n* Consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content. Required tumor tissue can be provided as either:\n\n * Pretreatment tumor biopsy from at least 1 lesion not previously irradiated and amenable to core biopsy OR\n * Archival tumor tissue collected from a biopsy performed within 3 months prior to signing of the tissue consent and since progression while on or after treatment with the most recent cancer therapy regimen.\n* Eastern Cooperative Oncology Group Performance Standard of 0 or 1 at Screening.\n* Has adequate bone marrow reserve and organ function based on local laboratory data within 14 days prior to Cycle 1 Day 1:\n\n * Platelet count : ≥100,000/mm\\^3 or ≥100 × 10\\^9/L (platelet transfusions are not allowed up to 14 days prior to Cycle 1 Day 1 to meet eligibility)\n * Hemoglobin: ≥9.0 g/dL (transfusion and/or growth factor support is allowed)\n * Absolute neutrophil count: ≥1500/mm\\^3 or ≥1.5 × 10\\^9/L\n * Serum creatinine (SCr) or creatinine clearance (CrCl): SCr ≤1.5 × upper limit of normal (ULN), OR CrCl ≥30 mL/min as calculated using the Cockcroft-Gault equation or measured CrCl\n * Aspartate aminotransferase/alanine aminotransferase: ≤3 × ULN (if liver metastases are present, ≤5 × ULN)\n * Total bilirubin: ≤1.5 × ULN if no liver metastases (\\<3 × ULN in the presence of documented Gilbert's syndrome \\[unconjugated hyperbilirubinemia\\] or liver metastases)\n * Serum albumin: ≥2.5 g/dL\n * Prothrombin time (PT) or PT-International normalized ratio (INR) and activated partial thromboplastin time (aPTT)/PTT: ≤1.5 × ULN, except for subjects on coumarin-derivative anticoagulants or other similar anticoagulant therapy, who must have PT-INR within therapeutic range as deemed appropriate by the Investigator\n\nExclusion Criteria:\n\nParticipants meeting any exclusion criteria for this study will be excluded from this study.\n\n* Any previous histologic or cytologic evidence of small cell OR combined small cell/non-small cell disease in the archival tumor tissue or pretreatment tumor biopsy.\n* Any history of interstitial lung disease (including pulmonary fibrosis or radiation pneumonitis), has current interstitial lung disease (ILD), or is suspected to have such disease by imaging during screening.\n* Clinically severe respiratory compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:\n\n * Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months prior to the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\]), restrictive lung disease, pleural effusion);\n * Any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis); OR prior complete pneumonectomy.\n* Is receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone or equivalent anti-inflammatory or any form of immunosuppressive therapy prior to enrollment. Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.\n* Evidence of any leptomeningeal disease.\n* Evidence of clinically active spinal cord compression or brain metastases.\n* Inadequate washout period prior to Cycle 1 Day 1, defined as:\n\n * Whole brain radiation therapy \\<14 days or stereotactic brain radiation therapy \\<7 days;\n * Any cytotoxic chemotherapy, investigational agent or other anticancer drug(s) from a previous cancer treatment regimen or clinical study (other than EGFR TKI), \\<14 days or 5 half-lives, whichever is longer;\n * Monoclonal antibodies, other than immune checkpoint inhibitors, such as bevacizumab (anti-VEGF) and cetuximab (anti-EGFR) \\<28 days;\n * Immune checkpoint inhibitor therapy \\<21 days;\n * Major surgery (excluding placement of vascular access) \\<28 days;\n * Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation \\<28 days or palliative radiation therapy \\<14 days; or\n * Chloroquine or hydroxychloroquine \\<14 days.\n* Prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody or single-agent topoisomerase I inhibitor.\n* Prior treatment with an antibody drug conjugate (ADC) that consists of any topoisomerase I inhibitor\n* Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, Grade ≤1 or baseline. Participants with chronic Grade 2 toxicities may be eligible at the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee.\n* Has history of other active malignancy within 3 years prior to enrollment, except:\n\n * Adequately treated non-melanoma skin cancer;\n * Superficial bladder tumors (Ta, Tis, T1);\n * Adequately treated intraepithelial carcinoma of the cervix uteri;\n * Low risk non-metastatic prostate cancer (with Gleason score \\<7, and following local treatment or ongoing active surveillance);\n * Any other curatively treated in situ disease.\n* Uncontrolled or significant cardiovascular disease prior to Cycle 1 Day 1\n* Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1.\n* Participant with any human immunodeficiency virus (HIV) infection."}, 'identificationModule': {'nctId': 'NCT04619004', 'briefTitle': 'HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'U31402-A-U201'}, 'secondaryIdInfos': [{'id': '2020-000730-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group 1: Patritumab deruxtecan 5.6 mg/kg', 'description': 'Study Group 1 will be participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation randomized to receive patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)', 'interventionNames': ['Drug: Patritumab Deruxtecan (Fixed dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Study Group 2: Patritumab deruxtecan Up-Titration', 'description': 'Study Group 2 will be participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation randomized to receive patritumab deruxtecan up-titration IV every 3 weeks (Q3W)', 'interventionNames': ['Drug: Patritumab Deruxtecan (Up-Titration)']}], 'interventions': [{'name': 'Patritumab Deruxtecan (Fixed dose)', 'type': 'DRUG', 'otherNames': ['U3-1402', 'HER3-DXd'], 'description': 'Patritumab deruxtecan will be dosed at 5.6 mg/kg as an intravenous (IV) infusion administered on Day 1 of each 21-day cycle.', 'armGroupLabels': ['Study Group 1: Patritumab deruxtecan 5.6 mg/kg']}, {'name': 'Patritumab Deruxtecan (Up-Titration)', 'type': 'DRUG', 'otherNames': ['U3-1402', 'HER3-DXd'], 'description': 'Patritumab deruxtecan will be dosed as an intravenous (IV) infusion administered at Cycle 1, 3.2 mg/kg; Cycle 2, 4.8 mg/kg; Cycle 3 and subsequent cycles, 6.4 mg/kg administered on Day 1 of each 21-day cycle.', 'armGroupLabels': ['Study Group 2: Patritumab deruxtecan Up-Titration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Moores Cancer Center at the UC San Diego Health', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Shores Medical Group', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90048', 'city': 'West Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai', 'geoPoint': {'lat': 34.09001, 'lon': -118.36174}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver - Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - South', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33021', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Healthcare System', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33770', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialist-North', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists-Panhandle', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. 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