Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

Metastatic Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05226598
• Other study ID #: 7684A-007
• Secondary ID: MK-7684A-007KEYV
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 24, 2022
• Est. completion date: September 27, 2027

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: September 27, 2027
• Est. primary completion date: November 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

• A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC.

• Has not received prior systemic treatment for metastatic NSCLC.

• Has measurable disease based on RECIST 1.1, as determined by the local site assessment.

• Has a life expectancy of at least 3 months.

• Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method.

Exclusion Criteria:

• Known additional malignancy that is progressing or has required active treatment within the past 3 years.

• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

• Severe hypersensitivity to MK-7684, MK-7684A, pembrolizumab, chemotherapy components, and/or any of its excipients.

• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.

• Active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)

• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

• Has an active infection requiring systemic therapy.

• Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus.

• Received prior systemic anticancer therapy for metastatic disease.

• Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.

• History of allogeneic tissue/solid organ transplant.

• Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose =1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).

• Is unable or unwilling to take folic acid or vitamin B12 supplementation.

• Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-Small Cell Lung Cancer

Intervention

Biological:
• Pembrolizumab/Vibostolimab
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations

Drug:
• Carboplatin
Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations
• Cisplatin
Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations
• Paclitaxel
Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations
• Nab-paclitaxel
Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations
• Pemetrexed
Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision

Biological:
• Pembrolizumab
Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209)	ABB	Caba
Argentina	Centro de Oncología e Investigación de Buenos Aires ( Site 0203)	Berazategui	Buenos Aires
Argentina	Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)	Buenos Aires	Caba
Argentina	Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206)	La Rioja
Argentina	Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204)	Mar del Plata	Buenos Aires
Argentina	Hospital Provincial del Centenario ( Site 0212)	Rosario	Santa Fe
Argentina	Sanatorio Parque ( Site 0205)	Rosario	Santa Fe
Austria	Medizinische Universität Graz ( Site 0704)	Graz	Steiermark
Austria	Medizinische Universitaet Innsbruck ( Site 0703)	Innsbruck	Tirol
Austria	Kepler Universitätsklinikum ( Site 0707)	Linz	Oberosterreich
Austria	Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705)	Linz	Oberosterreich
Austria	Klinik Penzing-2. Lungenabteilung ( Site 0702)	Vienna	Wien
Austria	Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701)	Wien
Brazil	Clínica de Oncologia Reichow ( Site 0407)	Blumenau	Santa Catarina
Brazil	Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403)	Natal	Rio Grande Do Norte
Brazil	Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405)	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406)	Rio de Janeiro
Brazil	Hospital Paulistano ( Site 0401)	Sao Paulo
Chile	Centro de Investigación Oncológica del Norte ( Site 0504)	Antofagasta
Chile	Biocenter ( Site 0514)	Concepción	Biobio
Chile	Bradfordhill ( Site 0510)	Santiago	Region M. De Santiago
Chile	Centro de Oncología de Precisión ( Site 0515)	Santiago	Region M. De Santiago
Chile	FALP-UIDO ( Site 0505)	Santiago	Region M. De Santiago
Chile	CIDO SpA-Oncology ( Site 0508)	Temuco	Araucania
Chile	James Lind Centro de Investigación del Cáncer ( Site 0502)	Temuco	Araucania
Chile	ONCOCENTRO APYS-ACEREY ( Site 0503)	Viña del Mar	Valparaiso
China	Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2602)	Beijing	Beijing
China	Jilin Cancer Hospital-oncology department ( Site 2603)	Changchun	Jilin
China	Hunan Cancer Hospital ( Site 2622)	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University ( Site 2623)	Changsha	Hunan
China	Xiangya Hospital Central South University-Oncology department ( Site 2627)	Changsha	Hunan
China	West China Hospital of Sichuan University ( Site 2610)	Cheng Du	Sichuan
China	Sichuan Cancer hospital ( Site 2628)	Chengdu	Sichuan
China	Fujian Provincial Cancer Hospital-oncology department ( Site 2621)	Fuzhou	Fujian
China	Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615)	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 2613)	Hangzhou	Zhejiang
China	The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital-Oncology ( Site 2612)	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital-oncology of department ( Site 2604)	Harbin	Heilongjiang
China	Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619)	Hefei	Anhui
China	Shandong Cancer Hospital-Oncology Department ( Site 2630)	Jinan	Shandong
China	The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625)	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624)	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (	Nanjing	Jiangsu
China	Fudan University Shanghai Cancer Center ( Site 2616)	Shanghai	Shanghai
China	Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)	Shanghai	Shanghai
China	Tianjin Medical University Cancer Institute and Hospital-lung cancer ( Site 2606)	Tianjin	Tianjin
China	Tongji Hospital Tongji Medical,Science & Technology ( Site 2617)	Wuhan	Hubei
China	Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618)	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607)	Xi'an	Shaanxi
China	The First Affiliated hospital of Xiamen University ( Site 2626)	Xiamen City	Fujian
China	The Second People's Hospital of Yibin ( Site 2629)	Yibin	Sichuan
China	Henan Cancer Hospital ( Site 2608)	Zhengzhou	Henan
Colombia	Administradora Country S.A. - Clinica del Country ( Site 0601)	Bogotá	Distrito Capital De Bogota
Colombia	Fundación Colombiana de Cancerología Clínica Vida ( Site 0603)	Medellin	Antioquia
Colombia	Oncomedica S.A.-Oncomedica S.A ( Site 0609)	Montería	Cordoba
Colombia	Oncologos del Occidente ( Site 0608)	Pereira	Risaralda
Colombia	Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)	Valledupar	Cesar
France	Institut de Cancérologie de l'Ouest ( Site 0802)	ANGERS cedex 02	Maine-et-Loire
France	Centre Hospitalier d'Avignon ( Site 0810)	Avignon	Vaucluse
France	Centre Hospitalier d'Annecy ( Site 0807)	Epagny Metz-Tessy	Haute-Savoie
France	Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th	Lille	Nord-Pas-de-Calais
France	CENTRE LEON BERARD ( Site 0803)	Lyon CEDEX 08	Rhone
France	CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806)	Orléans	Centre
France	HIA Sainte Anne ( Site 0804)	Toulon	Var
Germany	Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913	Berlin
Germany	GEFOS Gesellschaft f. onkologische Studien ( Site 0909)	Dortmund	Nordrhein-Westfalen
Germany	SRH Wald-Klinikum Gera ( Site 0911)	Gera	Thuringen
Germany	UKGM Gießen/Marburg-Medical Clinic V ( Site 0912)	Gießen	Hessen
Germany	Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)	Lübeck	Schleswig-Holstein
Israel	Rambam Health Care Campus-Oncology ( Site 1303)	Haifa
Israel	Shaare Zedek Medical Center-Oncology ( Site 1306)	Jerusalem
Israel	Meir Medical Center-oncology ( Site 1301)	Kfar Saba
Israel	Sheba Medical Center-ONCOLOGY ( Site 1302)	Ramat Gan
Israel	Sourasky Medical Center-Oncology ( Site 1305)	Tel Aviv
Japan	Hyogo Cancer Center-Thoracic Oncology ( Site 2409)	Akashi	Hyogo
Japan	National Hospital Organization Kyushu Cancer Center ( Site 2412)	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center ( Site 2413)	Fukuoka
Japan	Kansai Medical University Hospital ( Site 2415)	Hirakata	Osaka
Japan	Saitama Prefectural Cancer Center ( Site 2406)	Ina-machi	Saitama
Japan	Kanazawa University Hospital ( Site 2407)	Kanazawa	Ishikawa
Japan	Japanese Foundation for Cancer Research ( Site 2402)	Koto	Tokyo
Japan	National Hospital Organization Shikoku Cancer Center ( Site 2414)	Matsuyama	Ehime
Japan	Shizuoka Cancer Center ( Site 2408)	Nagaizumi	Shizuoka
Japan	Miyagi Cancer Center ( Site 2401)	Natori	Miyagi
Japan	Okayama University Hospital ( Site 2410)	Okayama
Japan	Showa University Hospital ( Site 2403)	Shinagawa	Tokyo
Japan	Nippon Medical School Hospital ( Site 2404)	Tokyo
Japan	Ehime University Hospital ( Site 2411)	Toon	Ehime
Japan	Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405)	Yokohama	Kanagawa
Korea, Republic of	Pusan National University Hospital ( Site 2205)	Busan	Pusan-Kwangyokshi
Korea, Republic of	Chungnam national university hospital-Department of Internal Medicine ( Site 2203)	Daejeon	Taejon-Kwangyokshi
Korea, Republic of	Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202)	Deagu	Taegu-Kwangyokshi
Korea, Republic of	Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201)	Hwasun	Jeonranamdo
Korea, Republic of	Korea University Guro Hospital-Internal Medicine ( Site 2204)	Seoul
Korea, Republic of	Asan Medical Center ( Site 2206)	Songpa-gu	Seoul
Mexico	Alivia Clínica de Alta Especialidad ( Site 0310)	Ciudad de Mexico	Distrito Federal
Mexico	Hospital Civil Fray Antonio Alcalde ( Site 0307)	Guadalajara	Jalisco
Mexico	Arké SMO S.A. de C.V. ( Site 0301)	Mexico	Distrito Federal
Mexico	CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304)	Saltillo	Coahuila
Poland	Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903)	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907)	Bystra	Slaskie
Poland	Przychodnia Lekarska KOMED ( Site 1902)	Konin	Wielkopolskie
Poland	Med-Polonia Sp. z o. o. ( Site 1909)	Poznan	Wielkopolskie
Poland	Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906)	Prabuty	Pomorskie
Poland	Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904)	Przemysl	Podkarpackie
Poland	Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908)	Warsaw	Mazowieckie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier	Warszawa	Mazowieckie
Spain	CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106)	A Coruña	La Coruna
Spain	Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)	Barcelona
Spain	Hospital Insular de Gran Canaria-Oncology ( Site 1102)	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Clinico San Carlos-Oncology Department ( Site 1107)	Madrid
Spain	Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103)	Sevilla
Spain	Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105)	Zaragoza
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254)	Kaohsiung
Taiwan	China Medical University Hospital ( Site 2253)	Taichung
Taiwan	NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252)	Tainan
Taiwan	National Taiwan University Hospital-Oncology ( Site 2255)	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch ( Site 2251)	Taoyuan
Thailand	Faculty of Medicine Siriraj Hospital ( Site 2304)	Bangkok	Krung Thep Maha Nakhon
Thailand	Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 2301)	Chiang Mai
Thailand	Songklanagarind hospital ( Site 2302)	Hatyai	Songkhla
Thailand	Chulabhorn Hospital ( Site 2305)	Lak Si	Krung Thep Maha Nakhon
Thailand	Faculty of Medicine - Khon Kaen University ( Site 2303)	Muang	Khon Kaen
Turkey	Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208)	Adana
Turkey	Ankara City Hospital ( Site 1204)	Ankara
Turkey	Hacettepe Universitesi-oncology hospital ( Site 1202)	Ankara
Turkey	Liv Hospital Ankara-Oncology ( Site 1205)	Ankara
Turkey	Trakya University-Medical Oncology ( Site 1203)	Edirne
Turkey	TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209)	Istanbul
Turkey	Umraniye Training and Research Hospital-medical oncology ( Site 1206)	Istanbul
Turkey	Acibadem Altunizade Hospital-Oncology ( Site 1207)	Üsküdar / Stanbul	Istanbul
United Kingdom	Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)	Leicester	England
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501)	London	England
United Kingdom	St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506)	London	London, City Of
United Kingdom	University College London Hospital-Cancer Clinical Trials Unit ( Site 1509)	London-Camden	London, City Of
United States	Charleston Oncology ( Site 0019)	Charleston	South Carolina
United States	University of Virginia Cancer Center ( Site 0018)	Charlottesville	Virginia
United States	Mount Sinai Hospital ( Site 0011)	Chicago	Illinois
United States	University of Chicago Medical Center ( Site 0015)	Chicago	Illinois
United States	UCHealth Memorial Hospital-Heme Onc ( Site 0003)	Colorado Springs	Colorado
United States	University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)	Fort Collins	Colorado
United States	Cancer and Hematology Centers of Western Michigan ( Site 0002)	Grand Rapids	Michigan
United States	Mayo Clinic in Florida ( Site 0022)	Jacksonville	Florida
United States	Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)	Lancaster	Pennsylvania
United States	Mayo Clinic in Rochester, Minnesota ( Site 0030)	Rochester	Minnesota
United States	New England Cancer Specialists ( Site 0008)	Scarborough	Maine
United States	Stony Brook University-Cancer Center ( Site 0013)	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Brazil,  Chile,  China,  Colombia,  France,  Germany,  Israel,  Japan,  Korea, Republic of,  Mexico,  Poland,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS is defined as the time from randomization to the date of death due to any cause.	Up to approximately 36 months
Secondary	Progression-Free Survival (PFS)	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is 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 is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.	Up to approximately 27 months
Secondary	Objective Response Rate (ORR)	ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.	Up to approximately 27 months
Secondary	Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "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). A higher score indicates a better overall outcome.	Baseline and Up to approximately 36 months
Secondary	Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30	Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.	Baseline and Up to approximately 36 months
Secondary	Change from Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30	Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.	Baseline and up to approximately 36 months
Secondary	Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30	Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.	Baseline and Up to approximately 36 months
Secondary	Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13)	Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.	Baseline and Up to approximately 36 months
Secondary	Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13	Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.	Baseline and Up to approximately 36 months
Secondary	Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30	TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "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). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.	Up to approximately 36 months
Secondary	TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ- C30	TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.	Up to approximately 36 months
Secondary	TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30	TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.	Up to approximately 36 months
Secondary	TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30	TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.	Up to approximately 36 months
Secondary	TTD in Cough Score (Item 31) on the EORTC QLQ-LC13	TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.	Up to approximately 36 months
Secondary	TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13	TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.	Up to approximately 36 months
Secondary	Number of Participants Who Experienced One or More Adverse Events (AEs)	The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.	Up to approximately 36 months
Secondary	Number of Participants Who Discontinued Study Intervention Due to an AE	The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.	Up to approximately 36 months
Secondary	Duration of Response (DOR)	For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.	Up to approximately 27 months

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary