Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 4:29 AM
Study NCT ID:
NCT05513703
Status:
TERMINATED
Last Update Posted:
2025-10-24
First Post:
2022-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China', 'Romania', 'Spain', 'Turkey (Türkiye)', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009369', 'term': 'Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626235', 'term': 'telisotuzumab vedotin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.', 'description': 'All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Telisotuzumab Vedotin', 'description': 'Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 4, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'LEUKOCYTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'HYPERTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'KERATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'DISEASE PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'MEDICAL DEVICE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'CHOLESTASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'ORAL FUNGAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'LIGAMENT SPRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'BLOOD ALKALINE PHOSPHATASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'BLOOD GLUCOSE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'BLOOD TESTOSTERONE DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'C-REACTIVE PROTEIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'LYMPHOCYTE COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'NEUTROPHIL COUNT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'WHITE BLOOD CELL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'HYPOALBUMINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'PERIPHERAL SENSORY NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'PRESYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'TASTE DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'PNEUMONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'PULMONARY HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'DISEASE PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'PNEUMONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) as Assessed by an Independent Central Review (ICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telisotuzumab Vedotin', 'description': 'Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '70.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 1.5 years', 'description': 'ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 as assessed by ICR.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telisotuzumab Vedotin', 'description': 'Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'comment': 'Not reached due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 1.5 years', 'description': 'DoR was defined for confirmed responders as the time from the initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1, or death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, "Overall number of participants analyzed" represents participants evaluable for this outcome measure with CR or PR.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telisotuzumab Vedotin', 'description': 'Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '13.7', 'upperLimit': '78.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 1.5 years', 'description': 'DCR was defined as the percentage of participants with best overall response of confirmed CR or confirmed PR, or stable disease (SD) for at least 12 weeks following first dose of study drug, based on RECIST, version 1.1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) Per ICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telisotuzumab Vedotin', 'description': 'Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'comment': 'Not reached due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 1.5 years', 'description': "PFS was defined as the time from the participant's first dose of study drug to the first occurrence of radiographic progression based on RECIST, version 1.1 or death from any cause.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telisotuzumab Vedotin', 'description': 'Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'comment': 'Not reached due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 1.5 years', 'description': "OS was defined as the time from participant's first dose of study drug to the event of death from any cause.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telisotuzumab Vedotin', 'description': 'Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.'}], 'classes': [{'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.33', 'spread': '15.430', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.11', 'spread': '34.427', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.56', 'spread': '13.608', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.11', 'spread': '17.213', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.33', 'spread': '29.814', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.67', 'spread': '27.889', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-25.00', 'spread': '31.914', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.67', 'spread': '14.907', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.33', 'spread': '18.257', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.33', 'spread': '16.667', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': '23.570', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-50.00', 'spread': '23.570', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': '23.570', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'spread': '47.140', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 19 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-50.00', 'spread': '23.570', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-50.00', 'spread': '23.570', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-50.00', 'spread': '23.570', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-50.00', 'spread': '23.570', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 32 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'spread': '47.140', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32', 'description': 'The cough item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telisotuzumab Vedotin', 'description': 'Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.'}], 'classes': [{'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.17', 'spread': '27.817', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.56', 'spread': '13.608', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.56', 'spread': '13.608', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '40.825', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.67', 'spread': '14.907', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '23.570', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '16.667', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': '23.570', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 19 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': '23.570', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not evaluable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 32 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32', 'description': 'The pain in chest item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telisotuzumab Vedotin', 'description': 'Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.'}], 'classes': [{'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.56', 'spread': '16.798', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.41', 'spread': '11.476', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.85', 'spread': '4.536', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.41', 'spread': '9.072', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.22', 'spread': '4.969', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.22', 'spread': '12.172', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '9.072', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.44', 'spread': '6.086', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.22', 'spread': '12.172', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.78', 'spread': '13.981', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.56', 'spread': '7.857', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.56', 'spread': '23.570', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.11', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.11', 'spread': '15.713', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.11', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 19 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '15.713', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.11', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.11', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.56', 'spread': '23.570', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.56', 'spread': '7.857', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '15.713', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.11', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 32 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '15.713', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32', 'description': 'The dyspnea item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telisotuzumab Vedotin', 'description': 'Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.'}], 'classes': [{'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.13', 'spread': '14.042', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.78', 'spread': '12.546', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.78', 'spread': '8.607', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.17', 'spread': '14.672', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '12.360', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.33', 'spread': '7.454', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.17', 'spread': '8.333', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.33', 'spread': '18.257', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.33', 'spread': '7.454', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.17', 'spread': '8.333', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '11.785', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '11.785', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '11.785', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.17', 'spread': '5.893', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 19 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.33', 'spread': '11.785', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.17', 'spread': '5.893', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '11.785', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.33', 'spread': '11.785', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 32 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': '23.570', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32', 'description': 'The Global Health Status/Quality of Life Domain of the EORTC QLQ-C30 was reported on a scale of 0 to 100, with higher scores indicating better global health status/functioning and a positive change from baseline indicating improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Telisotuzumab Vedotin', 'description': 'Participants received telisotuzumab vedotin by intravenous (IV) infusion every 2 weeks until they met study drug discontinuation criteria.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'A total of 9 participants were enrolled and received at least 1 dose of study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Telisotuzumab Vedotin', 'description': 'Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.4', 'spread': '11.20', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-07', 'size': 1669536, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-13T14:15', 'hasProtocol': True}, {'date': '2023-04-25', 'size': 359694, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-13T14:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Strategic considerations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04830202', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2022-08-23', 'resultsFirstSubmitDate': '2025-10-13', 'studyFirstSubmitQcDate': '2022-08-23', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-13', 'studyFirstPostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) as Assessed by an Independent Central Review (ICR)', 'timeFrame': 'Up to approximately 1.5 years', 'description': 'ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 as assessed by ICR.'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DoR)', 'timeFrame': 'Up to approximately 1.5 years', 'description': 'DoR was defined for confirmed responders as the time from the initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1, or death from any cause.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to approximately 1.5 years', 'description': 'DCR was defined as the percentage of participants with best overall response of confirmed CR or confirmed PR, or stable disease (SD) for at least 12 weeks following first dose of study drug, based on RECIST, version 1.1.'}, {'measure': 'Progression Free Survival (PFS) Per ICR', 'timeFrame': 'Up to approximately 1.5 years', 'description': "PFS was defined as the time from the participant's first dose of study drug to the first occurrence of radiographic progression based on RECIST, version 1.1 or death from any cause."}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 1.5 years', 'description': "OS was defined as the time from participant's first dose of study drug to the event of death from any cause."}, {'measure': 'Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32', 'description': 'The cough item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.'}, {'measure': 'Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32', 'description': 'The pain in chest item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.'}, {'measure': 'Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32', 'description': 'The dyspnea item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.'}, {'measure': 'Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32', 'description': 'The Global Health Status/Quality of Life Domain of the EORTC QLQ-C30 was reported on a scale of 0 to 100, with higher scores indicating better global health status/functioning and a positive change from baseline indicating improvement.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['c-Met NSCLC', 'Telisotuzumab Vedotin', 'ABBV-399', 'Cancer', 'Non Small Cell Lung Cancer', 'NSCLC', 'MET Amplified NSCLC'], 'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M22-137', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed.\n\nTelisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide.\n\nParticipants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must have MET amplification in tumor tissue as determined by the Sponsor-designated central laboratory MET FISH Assay or in plasma and/or tissue by a Sponsor-approved assay.\n* Must have histologically documented non-squamous adenocarcinoma non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.\n* Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Participant may have received prior adjuvant/neoadjuvant systemic chemotherapy and/or radiation and/or immunotherapy provided that the subject has not progressed on or within 6 months of completing the regimen and it was completed \\>= 6 months before subject's first dose of study drug.\n* Metastases to the central nervous system (CNS) are eligible only after definitive therapy is provided as noted in the protocol.\n* History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n\nExclusion Criteria:\n\n* Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy. Participants with other alterations that are candidates for available targeted therapy.\n* Prior systemic therapy for locally advanced/metastatic NSCLC. Of note, limited treatment with no more than 1 cycle of chemotherapy is allowed prior to receiving the first dose of study drug provided there is no evidence of progression.\n* Have a history of other malignancies except those noted in the protocol.\n* Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n* Received prior c-Met-targeted antibodies.\n* Have NSCLC that is eligible for treatment with curative intent.\n* Have unresolved adverse events (AEs) \\>= Grade 2 from prior anticancer therapy, except for alopecia or anemia.\n* Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.\n* Have clinically significant condition(s) as noted in the protocol."}, 'identificationModule': {'nctId': 'NCT05513703', 'briefTitle': 'A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'M22-137'}, 'secondaryIdInfos': [{'id': '2022-500608-23-00', 'type': 'OTHER', 'domain': 'EU CT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telisotuzumab Vedotin', 'description': 'Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.', 'interventionNames': ['Biological: Telisotuzumab Vedotin']}], 'interventions': [{'name': 'Telisotuzumab Vedotin', 'type': 'BIOLOGICAL', 'otherNames': ['ABBV-399'], 'description': 'Intravenous (IV) Infusion', 'armGroupLabels': ['Telisotuzumab Vedotin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90720-3309', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Cancer and Blood Speciality Clinic - Los Alamitos /ID# 251671', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '98055-5738', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Valley Medical Center /ID# 251880', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Health - Monash Medical Centre /ID# 247679', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '59037', 'city': 'Lille', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'CHU Lille - Hôpital Albert Calmette /ID# 246263', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69500', 'city': 'Bron', 'state': 'Rhone', 'country': 'France', 'facility': 'Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 246267', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin /ID# 246268', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '82131', 'city': 'Gauting', 'country': 'Germany', 'facility': 'Asklepios Fachkliniken Muenchen-Gauting /ID# 248082', 'geoPoint': {'lat': 48.06919, 'lon': 11.37703}}, {'zip': '4428164', 'city': 'Kfar Saba', 'state': 'Central District', 'country': 'Israel', 'facility': 'Meir Medical Center /ID# 243208', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '3109601', 'city': 'Haifa', 'state': 'H_efa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus /ID# 246781', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91120', 'city': 'Jerusalem', 'state': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center-Hebrew University /ID# 243298', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '5265601', 'city': 'Ramat Gan', 'state': 'Tel Aviv', 'country': 'Israel', 'facility': 'The Chaim Sheba Medical Center /ID# 243207', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '4941492', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center /ID# 248631', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '20900', 'city': 'Monza', 'state': 'Monza E Brianza', 'country': 'Italy', 'facility': 'Duplicate_Fondazione IRCCS San Gerardo dei Tintori /ID# 247584', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '10060', 'city': 'Candiolo', 'state': 'Torino', 'country': 'Italy', 'facility': "Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 248329", 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}, {'zip': '00144', 'city': 'Rome', 'country': 'Italy', 'facility': 'IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 247585', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '277-8577', 'city': 'Kashiwa-shi', 'state': 'Chiba', 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