Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-02-21 @ 8:27 PM
Study NCT ID:
NCT03829332
Status:
COMPLETED
Last Update Posted:
2025-04-16
First Post:
2019-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'C531958', 'term': 'lenvatinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 61 months', 'description': 'All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \\& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Lenvatinib + Pembrolizumab', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.', 'otherNumAtRisk': 309, 'deathsNumAtRisk': 309, 'otherNumAffected': 296, 'seriousNumAtRisk': 309, 'deathsNumAffected': 229, 'seriousNumAffected': 192}, {'id': 'EG001', 'title': 'Placebo + Pembrolizumab', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.', 'otherNumAtRisk': 312, 'deathsNumAtRisk': 314, 'otherNumAffected': 275, 'seriousNumAtRisk': 312, 'deathsNumAffected': 232, 'seriousNumAffected': 118}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 84, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 88, 'numAffected': 68}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 35, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 25, 'numAffected': 20}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 171, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 36, 'numAffected': 35}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 33, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 42, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 50, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 208, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 62, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 116, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 76, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 71, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 56, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 26, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 86, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 37, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 58, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 40, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 42, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 42, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 41, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 39, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 33, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 79, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 42, 'numAffected': 32}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 45, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 89, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 49, 'numAffected': 32}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 47, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 29, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 23, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 50, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 46, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 98, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 27, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 92, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 55, 'numAffected': 51}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 39, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 30, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 39, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 31, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 34, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 28, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 49, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 29, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 50, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 43, 'numAffected': 33}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 40, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 25, 'numAffected': 17}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 169, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 55, 'numAffected': 36}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 38, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 27, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 36, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 29, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 29, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 49, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 44, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 33, 'numAffected': 29}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 57, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 37, 'numAffected': 33}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 150, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 52, 'numAffected': 46}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac ventricular thrombosis', 'stats': 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'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vancomycin infusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Embolism arterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '8.2'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '6.2'}]}]}], 'analyses': [{'pValue': '0.00624', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.95', 'groupDescription': "Hazards ratio (HR) and 95% confidence interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%).", 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'One-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 25 months', 'description': 'PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 was presented.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized participants.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '19.0'}, {'value': '16.4', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '20.6'}]}]}], 'analyses': [{'pValue': '0.79744', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.39', 'groupDescription': "HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%).", 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'One-sided p-value based on log-rank test stratified by ECOG, region, and baseline PD-L1 status.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 25 months', 'description': 'OS was defined as the time from date of randomization to date of death from any cause. OS was presented.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '46.2'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '22.8', 'upperLimit': '33.0'}]}]}], 'analyses': [{'pValue': '0.00037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.8', 'ciLowerLimit': '5.4', 'ciUpperLimit': '20.1', 'groupDescription': 'Percent difference and 95% CI were calculated using Miettinen \\& Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%).', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \\> 0.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 25 months', 'description': 'ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR per RECIST 1.1 is presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '306', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 90 days post last dose of study treatment (Up to approximately 27 months)', 'description': 'An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE were reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through last dose of study treatment (Up to approximately 24 months)', 'description': 'An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core30 (QLQ-C30) Combined Global Health Status/Quality of Life (Items 29 & 30) Scale Combined Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.48', 'groupId': 'OG000', 'lowerLimit': '-4.09', 'upperLimit': '1.13'}, {'value': '2.42', 'groupId': 'OG001', 'lowerLimit': '-0.24', 'upperLimit': '5.08'}]}]}], 'analyses': [{'pValue': '0.0262', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.90', 'ciLowerLimit': '-7.34', 'ciUpperLimit': '-0.47', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \\& baseline PDL-1.', 'nonInferiorityComment': 'Difference in LS means and 95% CI were calculated using the Constrained longitudinal data analysis (cLDA) model with covariates for treatment by study visit interaction \\& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 21', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in GHS and QoL combined score was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have received at least one dose of the study intervention and had at least one EORTC QLQ-C30 assessment data available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.53', 'groupId': 'OG000', 'lowerLimit': '-12.94', 'upperLimit': '-6.13'}, {'value': '-5.04', 'groupId': 'OG001', 'lowerLimit': '-8.51', 'upperLimit': '-1.57'}]}]}], 'analyses': [{'pValue': '0.0461', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.50', 'ciLowerLimit': '-8.91', 'ciUpperLimit': '-0.08', 'pValueComment': 'Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \\& baseline PDL-1.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \\& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 21', 'description': 'The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in cough (EORTC QLQ-LC13 Item 31) score was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 31 assessment data available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.64', 'groupId': 'OG000', 'lowerLimit': '-7.45', 'upperLimit': '-1.84'}, {'value': '-3.55', 'groupId': 'OG001', 'lowerLimit': '-6.42', 'upperLimit': '-0.68'}]}]}], 'analyses': [{'pValue': '0.5596', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.10', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '2.59', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \\& baseline PDL-1.', 'nonInferiorityComment': 'Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \\& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 21', 'description': 'The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-LC13 chest pain (Item 40) score was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 40 assessment data available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.35', 'groupId': 'OG000', 'lowerLimit': '-4.75', 'upperLimit': '2.04'}, {'value': '-0.47', 'groupId': 'OG001', 'lowerLimit': '-3.94', 'upperLimit': '3.00'}]}]}], 'analyses': [{'pValue': '0.7088', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.88', 'ciLowerLimit': '-5.49', 'ciUpperLimit': '3.74', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \\& baseline PDL-1.', 'nonInferiorityComment': 'Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \\& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 21', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question: "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 8 assessment data available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.73', 'groupId': 'OG000', 'lowerLimit': '-9.35', 'upperLimit': '-4.10'}, {'value': '-3.72', 'groupId': 'OG001', 'lowerLimit': '-6.40', 'upperLimit': '-1.04'}]}]}], 'analyses': [{'pValue': '0.1116', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.01', 'ciLowerLimit': '-6.71', 'ciUpperLimit': '0.70', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \\& baseline PDL-1.', 'nonInferiorityComment': 'Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \\& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 21', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Items 1-5 assessment data available.'}, {'type': 'SECONDARY', 'title': 'Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status /Quality of Life (Items 29 & 30) Scale Combined Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Median and upper limit of 95%CI was not reached due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Median and upper limit of 95%CI was not reached due to insufficient number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': '19.3', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.9601', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.33', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.', 'nonInferiorityComment': "HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%)."}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 25 months', 'description': 'EORTC QLQ-C30 is a questionnaire to assess QoL of cancer patients. Participant responses to questions on GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall QoL during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) was computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in GHS-QoL combined score. A longer TTD indicates a better outcome.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 29 and Item 30 assessment data available.'}, {'type': 'SECONDARY', 'title': 'Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Median, lower and upper limit of 95%CI was not reached due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Median, lower and upper limit of 95%CI was not reached due to insufficient number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0079', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.88', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.', 'nonInferiorityComment': "HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%)."}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 25 months', 'description': 'EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question: "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 31). A longer TTD indicates a better outcome.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-LC13 Item assessment data available.'}, {'type': 'SECONDARY', 'title': 'Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Median, lower and upper limit of 95%CI were not reached due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Median, lower and upper limit of 95%CI were not reached due to insufficient number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.7457', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.56', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.', 'nonInferiorityComment': "HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%)."}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 25 months', 'description': 'EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question: "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 40). A longer TTD indicates a better outcome.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-LC13 Item 40 assessment data available.'}, {'type': 'SECONDARY', 'title': 'Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Median, lower and upper limit of 95%CI were not reached due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Median and upper limit of 95%CI were not reached due to insufficient number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': '20.8', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.8122', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.44', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.', 'nonInferiorityComment': "HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%)."}], 'paramType': 'MEAN', 'timeFrame': 'Up to approximately 25 months', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question: "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in dyspnea (Item 8). A longer TTD indicates a better outcome.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ Item 8 assessment data available.'}, {'type': 'SECONDARY', 'title': 'Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'comment': 'NA = Upper limit of 95%CI could not be reached due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Median and upper limit of 95%CI could not be reached due to insufficient number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.1480', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.67', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.', 'nonInferiorityComment': "HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%)."}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 25 months', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in physical functioning (Items 1 to 5). A longer TTD indicates a better outcome.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Items 1-5 assessment data available.'}, {'type': 'SECONDARY', 'title': 'Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.78', 'comment': 'NA = Upper limit of 95%CI could not be reached due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '2.79', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Median and upper limit of 95%CI could not be reached due to insufficient number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': '3.45', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.4068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.70', 'ciUpperLimit': '2.46', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.', 'nonInferiorityComment': "HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \\>=50%)."}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 25 months', 'description': 'The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a single-item scale score for dyspnea (Item 8; score range:1=Not at All to 4=Very Much). Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for cough (Item 31; score range:1=Not at All to 4=Very Much ) and chest pain (Item 40, score range: 1=Not at All to 4=Very Much). The combined score of items 31, 40 and 8 was computed by averaging the raw scores of the items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD in the composite endpoint of EORTC QLQ-LC13 Item 31, EORTC QLQ-LC13 Item 40, EORTC QLQ-C30 Item 8 scale score was presented, defined as the time to first onset of a ≥10point decrease from baseline in anyone of the three scale items. A longer TTD indicates better outcome.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and have at least one had at least one EORTC-QLQ-C30 or EORTC QLQ-LC13 assessment data available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'FG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '314'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '312'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '314'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '230'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Of the 623 total participants randomized in the MK-7902-007 global study, 80 were also randomized in the China extension study for MK-7902-007 (NCT04676412).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}, {'value': '314', 'groupId': 'BG001'}, {'value': '623', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'BG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '65.4', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '65.0', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '454', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '535', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'title': 'ECOG = 0', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}]}, {'title': 'ECOG = 1', 'categories': [{'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '405', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Randomization of participants in the study was stratified by an ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature).', 'unitOfMeasure': 'Participants'}, {'title': 'Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline', 'classes': [{'title': 'TPS = 1-49%', 'categories': [{'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '347', 'groupId': 'BG002'}]}]}, {'title': 'TPS = ≥ 50%', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Randomization of participants in the study was stratified by PD-L1 tumor proportion score (TPS) at baseline (1-49% or ≥ 50%). Higher percentages of PD-L1 TPS staining correspond to higher positivity of PD-L1 on a tumor.', 'unitOfMeasure': 'Participants'}, {'title': 'Geographic Region', 'classes': [{'title': 'East Asia', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}]}, {'title': 'Non-East Asia', 'categories': [{'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Randomization of participants in this study was stratified by geographic region of the enrolling site (East Asia or non-East Asia).', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-18', 'size': 1970249, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-26T09:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 623}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2019-02-01', 'resultsFirstSubmitDate': '2022-05-06', 'studyFirstSubmitQcDate': '2019-02-01', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-06', 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 25 months', 'description': 'PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 was presented.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 25 months', 'description': 'OS was defined as the time from date of randomization to date of death from any cause. OS was presented.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 25 months', 'description': 'ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR per RECIST 1.1 is presented.'}, {'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Through 90 days post last dose of study treatment (Up to approximately 27 months)', 'description': 'An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE were reported'}, {'measure': 'Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)', 'timeFrame': 'Through last dose of study treatment (Up to approximately 24 months)', 'description': 'An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE were reported.'}, {'measure': 'Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core30 (QLQ-C30) Combined Global Health Status/Quality of Life (Items 29 & 30) Scale Combined Score', 'timeFrame': 'Baseline and Week 21', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in GHS and QoL combined score was presented.'}, {'measure': 'Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score', 'timeFrame': 'Baseline and Week 21', 'description': 'The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in cough (EORTC QLQ-LC13 Item 31) score was presented.'}, {'measure': 'Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score', 'timeFrame': 'Baseline and Week 21', 'description': 'The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-LC13 chest pain (Item 40) score was presented.'}, {'measure': 'Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score', 'timeFrame': 'Baseline and Week 21', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question: "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score was presented.'}, {'measure': 'Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score', 'timeFrame': 'Baseline and Week 21', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score was presented.'}, {'measure': 'Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status /Quality of Life (Items 29 & 30) Scale Combined Score', 'timeFrame': 'Up to approximately 25 months', 'description': 'EORTC QLQ-C30 is a questionnaire to assess QoL of cancer patients. Participant responses to questions on GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall QoL during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) was computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in GHS-QoL combined score. A longer TTD indicates a better outcome.'}, {'measure': 'Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score', 'timeFrame': 'Up to approximately 25 months', 'description': 'EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question: "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 31). A longer TTD indicates a better outcome.'}, {'measure': 'Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score', 'timeFrame': 'Up to approximately 25 months', 'description': 'EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question: "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 40). A longer TTD indicates a better outcome.'}, {'measure': 'Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score', 'timeFrame': 'Up to approximately 25 months', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question: "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in dyspnea (Item 8). A longer TTD indicates a better outcome.'}, {'measure': 'Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score', 'timeFrame': 'Up to approximately 25 months', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in physical functioning (Items 1 to 5). A longer TTD indicates a better outcome.'}, {'measure': 'Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)', 'timeFrame': 'Up to approximately 25 months', 'description': 'The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a single-item scale score for dyspnea (Item 8; score range:1=Not at All to 4=Very Much). Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for cough (Item 31; score range:1=Not at All to 4=Very Much ) and chest pain (Item 40, score range: 1=Not at All to 4=Very Much). The combined score of items 31, 40 and 8 was computed by averaging the raw scores of the items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD in the composite endpoint of EORTC QLQ-LC13 Item 31, EORTC QLQ-LC13 Item 40, EORTC QLQ-C30 Item 8 scale score was presented, defined as the time to first onset of a ≥10point decrease from baseline in anyone of the three scale items. A longer TTD indicates better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['programmed cell death 1 (PD-1, PD1)', 'programmed cell death-ligand 1 (PD-L1, PDL1)', 'programmed cell death-ligand 2 (PD-L2, PDL2)'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '38159809', 'type': 'RESULT', 'citation': 'Yang JC, Han B, De La Mora Jimenez E, Lee JS, Koralewski P, Karadurmus N, Sugawara S, Livi L, Basappa NS, Quantin X, Dudnik J, Ortiz DM, Mekhail T, Okpara CE, Dutcus C, Zimmer Z, Samkari A, Bhagwati N, Csoszi T. Pembrolizumab With or Without Lenvatinib for First-Line Metastatic NSCLC With Programmed Cell Death-Ligand 1 Tumor Proportion Score of at least 1% (LEAP-007): A Randomized, Double-Blind, Phase 3 Trial. J Thorac Oncol. 2024 Jun;19(6):941-953. doi: 10.1016/j.jtho.2023.12.023. Epub 2023 Dec 29.'}, {'pmid': '33300372', 'type': 'DERIVED', 'citation': 'Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trial Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.\n\nThe primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).', 'detailedDescription': 'As of 30-Jul-2021, active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue lenvatinib and placebo, and participants who remain on treatment will receive open-label pembrolizumab only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)\n* Has Stage IV NSCLC (American Joint Committee on Cancer \\[AJCC 8th edition\\])\n* Has measurable disease based on RECIST 1.1\n* Has tumor tissue that demonstrates programmed cell death-ligand 1 (PD-L1) expression in ≥1% of tumor cells (Tumor Proportion Score \\[TPS\\] ≥1%) as assessed by immunohistochemistry (IHC) 22C3 pharmDx assay (Dako North America, Inc.) at a central laboratory\n* Has a life expectancy of ≥3 months\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study treatment but before randomization\n* Male participants must agree to the following during the treatment period and for ≥7 days after the last dose of lenvatinib/matching placebo: 1) Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR 2) Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)\n* Female participants are eligible to participate if not pregnant or breastfeeding, and ≥1 of the following applies: 1) Is not a woman of child-bearing potential (WOCBP), OR 2) Is a WOCBP and is using a highly effective contraceptive method that has a low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and for ≥120 days post pembrolizumab or ≥30 days post lenvatinib/matching placebo, whichever occurs last\n* Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week before randomization\n* Has adequate organ function\n\nExclusion Criteria:\n\n* Has known untreated central nervous system metastases and/or carcinomatous meningitis\n* Has active hemoptysis (at least 0.5 teaspoon of bright red blood) within 2 weeks prior to the first dose of study intervention\n* Has radiographic evidence of intratumoral cavitations, encasement, or invasion of a major blood vessel\n* Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for ≥3 years since initiation of that therapy. (Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.)\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed\n* Has had an allogeneic tissue/solid organ transplant\n* Has a known history of human immunodeficiency virus (HIV) infection\n* Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease\n* Has a known history of hepatitis B or known active hepatitis C virus infection\n* Has a history of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral study drug absorption.\n* Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as a history of congestive heart failure greater than New York Heart Association Class II, unstable angina, myocardial infarction, cerebrovascular accident/stroke, or cardiac arrhythmia associated with hemodynamic instability\n* Has not recovered adequately from any toxicity and/or complications from major surgery before starting study treatment\n* Has a known history of active tuberculosis (TB)\n* Has an active infection requiring systemic therapy\n* Has previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has a known sensitivity or intolerance to any component of lenvatinib or pembrolizumab\n* Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 \\[CTLA-4\\], Tumor necrosis factor receptor superfamily, member 4 \\[OX 40\\], tumor necrosis factor receptor superfamily member 9 \\[CD137\\]) or has received lenvatinib as monotherapy or in combination with anti- programmed cell death protein (anti-PD-1) agents\n* Has received radiotherapy within 14 days before the first dose of study treatment or received lung radiation therapy of \\>30 Gray (Gy) within 6 months before the first dose of study treatment. (Note: Participants must have recovered from all radiation-related toxicities to ≤Grade 1, not require corticosteroids, and not have had radiation pneumonitis.)\n* Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days before the first dose of study treatment\n* Is receiving systemic steroid therapy (doses \\>10 mg daily of prednisone equivalent) within 7 days before the first dose of study treatment\n* Has received a live or attenuated vaccine within 30 days before the first dose of study treatment\n* Has had major surgery within 3 weeks prior to first dose of study treatment\n* Has pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula'}, 'identificationModule': {'nctId': 'NCT03829332', 'briefTitle': 'Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)', 'orgStudyIdInfo': {'id': '7902-007'}, 'secondaryIdInfos': [{'id': 'MK-7902-007', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'E7080-G000-314', 'type': 'OTHER', 'domain': 'Eisai Protocol Number'}, {'id': 'LEAP-007', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '194670', 'type': 'REGISTRY', 'domain': 'JAPIC-CTI'}, {'id': '2018-003794-98', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab + Lenvatinib', 'description': 'Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Lenvatinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pembrolizumab + Placebo', 'description': 'Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Placebo for lenvatinib']}], 'interventions': [{'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-3475', 'KEYTRUDA®'], 'description': 'IV infusion', 'armGroupLabels': ['Pembrolizumab + Lenvatinib', 'Pembrolizumab + Placebo']}, {'name': 'Lenvatinib', 'type': 'DRUG', 'otherNames': ['MK-7902', 'E7080', 'LENVIMA®'], 'description': 'oral capsule', 'armGroupLabels': ['Pembrolizumab + Lenvatinib']}, {'name': 'Placebo for lenvatinib', 'type': 'DRUG', 'description': 'oral capsule', 'armGroupLabels': ['Pembrolizumab + Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99503', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Clinical Research Center ( Site 0511)', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Ironwood Cancer & Research Centers ( Site 0541)', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'CBCC Global Research, Inc. 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