Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator-Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-line Treatment in Participants With PD L1 TPS Greater Than or Equal to 50% Metastatic Non-small Cell Lung Cancer (KEYNOTE D46/EVOKE-03)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05609968
• Other study ID #: 3475-D46
• Secondary ID: MK-3475-D46PHRR2
• Status: Recruiting
• Phase: Phase 3
• Start date: February 6, 2023
• Est. completion date: August 23, 2028

Study information

• Verified date: June 2024
• Source: Merck Sharp & Dohme LLC
• Contact: Toll Free Number
• Phone: 1-888-577-8839
• Email: Trialsites[@]merck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 614
• Est. completion date: August 23, 2028
• Est. primary completion date: January 12, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Has a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)

• Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase 1 (ALK-1), or ROS proto-oncogene 1 (ROS-1)-directed therapy is not indicated as primary therapy

• Has provided tumor tissue that demonstrates PD-L1 tumor proportion score (TPS) =50% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory

• Has a life expectancy of at least 3 months

Exclusion Criteria:

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

• Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years

• Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC

• Has previously received treatment with Topoisomerase 1 inhibitors or Trop-2 targeted therapy

• Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor

• Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicities requiring corticosteroids

• Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study intervention

• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

• Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration

• Has cardiac disease

• Myocardial infarction or unstable angina pectoris within 6 months of enrollment

• History of serious ventricular arrhythmia, high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications; history of QT interval prolongation

• New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of <40%

• Has active chronic inflammatory bowel disease

• Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication

• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

• Has severe hypersensitivity (=Grade 3) to pembrolizumab or sacituzumab govitecan and/or any of their excipients

• Has active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy

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

• Has active infection requiring systemic therapy

• Has history of human immunodeficiency virus (HIV) infection

• History of hepatitis B or known active hepatitis C virus infection

• Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator

• Have not adequately recovered from major surgery or have ongoing surgical complications

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Biological:
• Sacituzumab Govitecan
IV infusion
• Pembrolizumab
IV infusion

Locations

Country	Name	City	State
Australia	Cancer Research SA-St Andrews Hospital ( Site 0603)	Adelaide	South Australia
Australia	Frankston Hospital-Oncology and Haematology ( Site 0601)	Frankston	Victoria
Australia	Orange Hospital-Clinical Trials Unit ( Site 0600)	Orange	New South Wales
Brazil	Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0318)	Barretos	Sao Paulo
Brazil	Hospital Tacchini ( Site 0322)	Bento Goncalves	Rio Grande Do Sul
Brazil	CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0320)	Fortaleza	Ceara
Brazil	Hospital da Cidade de Passo Fundo ( Site 0321)	Passo Fundo	Rio Grande Do Sul
Brazil	Instituto de Oncologia Saint Gallen ( Site 0317)	Santa Cruz do Sul	Rio Grande Do Sul
Brazil	A. C. Camargo Cancer Center ( Site 0324)	Sao Paulo
Canada	BC Cancer Abbotsford-Medical Oncology ( Site 0433)	Abbotsford	British Columbia
Canada	Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0430)	Greenfield Park	Quebec
Canada	St. Marys Hospital Center-Oncology ( Site 0434)	Montreal	Quebec
Canada	Southlake Regional Health Centre-Oncology Clinical Trials ( Site 0435)	Newmarket	Ontario
Canada	Centre integre universitaire de sante et de services sociaux-oncology ( Site 0431)	Trois-Rivières	Quebec
Chile	Oncovida ( Site 0334)	Santiago	Region M. De Santiago
Chile	Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0332)	Santiago	Region M. De Santiago
China	Beijing Cancer hospital ( Site 0104)	Beijing	Beijing
China	Beijing Chest Hospital,Capital Medical University ( Site 0105)	Beijing	Beijing
China	Beijing Peking Union Medical College Hospital-pneumology department ( Site 0106)	Beijing	Beijing
China	Jilin Province Tumor Hospital ( Site 0118)	Changchun	Jilin
China	The First Hospital of Jilin University ( Site 0117)	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University ( Site 0135)	Changsha	Hunan
China	Xiangya Hospital Central South University ( Site 0124)	Changsha	Hunan
China	West China Hospital of Sichuan University ( Site 0129)	Cheng Du	Sichuan
China	Sichuan Cancer hospital ( Site 0128)	Chengdu	Sichuan
China	Chongqing University Cancer Hospital-Medical Oncology ( Site 0130)	Chongqing	Chongqing
China	Fujian Provincial Cancer Hospital ( Site 0131)	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 0111)	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University ( Site 0109)	Hangzhou	Zhejiang
China	The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0110)	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital ( Site 0108)	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital ( Site 0119)	Harbin	Heilongjiang
China	Anhui Provincial Hospital ( Site 0136)	Hefei	Anhui
China	Second Affiliated hospital of Anhui Medical University ( Site 0126)	Hefei	Anhui
China	Jinan Central Hospital-oncology department ( Site 0121)	Jinan	Shandong
China	LinYi Cancer Hospital ( Site 0120)	Linyi	Shandong
China	The Second Affiliated Hospital of Nanchang University ( Site 0134)	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0112	NanJing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hospital-Respiratory Oncology ( Site 0113)	Nanning	Guangxi
China	Nantong Tumor Hospital-Medical Oncology ( Site 0122)	Nantong	Jiangsu
China	Fudan University Shanghai Cancer Center-Oncology ( Site 0102)	Shanghai	Shanghai
China	Huashan Hospital, Fudan University ( Site 0103)	Shanghai	Shanghai
China	Shanghai Chest Hospital ( Site 0101)	Shanghai	Shanghai
China	The First Affliated Hospital of Suzhou University ( Site 0114)	Suzhou	Jiangsu
China	Hubei Cancer Hospital ( Site 0107)	Wuhan	Hubei
China	Tongji Hospital Tongji Medical,Science & Technology ( Site 0116)	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0115)	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0133)	Xi'an	Shaanxi
China	The First Affiliated hospital of Xiamen University ( Site 0132)	Xiamen	Fujian
China	Henan Cancer Hospital ( Site 0127)	Zhengzhou	Henan
Estonia	North Estonia Medical Centre Foundation-Chemotherapy ( Site 0621)	Tallinn	Harjumaa
Estonia	Tartu University Hospital-Radiotherapy and oncology ( Site 0620)	Tartu	Tartumaa
Germany	Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 0653)	Berlin
Germany	Vivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- (	Berlin
Germany	Krankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 0657)	Halle	Sachsen-Anhalt
Germany	Klinikum Kempten ( Site 0655)	Kempten	Bayern
Germany	Katholisches Klinikum Koblenz ( Site 0650)	Koblenz	Rheinland-Pfalz
Germany	Universitätsmedizin Mannheim ( Site 0654)	Mannheim	Baden-Wurttemberg
Germany	Klinikum Würzburg Mitte ( Site 0651)	Wuerzburg	Bayern
Greece	Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 0141)	Athens	Attiki
Greece	Sotiria Thoracic Diseases Hospital of Athens-3rd Dept of Internal Medicine, Oncology Unit ( Site 014	Athens	Attiki
Greece	European Interbalkan Medical Center-Oncology Department ( Site 0142)	Thessaloniki
Israel	Shaare Zedek Medical Center-Oncology ( Site 0176)	Jerusalem
Israel	Meir Medical Center-oncology ( Site 0171)	KfarSaba
Israel	Rabin Medical Center-Oncology ( Site 0174)	Petah Tikva
Israel	Sourasky Medical Center-Oncology ( Site 0175)	Tel Aviv
Israel	Yitzhak Shamir Medical Center. ( Site 0179)	Zerifin
Italy	Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0674)	Bergamo	Lombardia
Italy	Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0675)	Firenze	Toscana
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0673)	Milan	Lombardia
Italy	Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 0671)	Naples	Napoli
Italy	Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 0676)	Parma
Italy	Casa di Cura Dott. Pederzoli-LUNG-UNIT TORACIC ( Site 0670)	Peschiera del Garda	Verona
Italy	Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0677)	Roma	Lazio
Japan	Kyushu University Hospital ( Site 0010)	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center ( Site 0009)	Fukuoka
Japan	Kansai Medical University Hospital ( Site 0005)	Hirakata	Osaka
Japan	Saitama Prefectural Cancer Center ( Site 0002)	Ina-machi	Saitama
Japan	Kanazawa University Hospital ( Site 0019)	Kanazawa	Ishikawa
Japan	Kurashiki Central Hospital ( Site 0011)	Kurashiki	Okayama
Japan	Kurume University Hospital ( Site 0014)	Kurume	Fukuoka
Japan	National Hospital Organization Shikoku Cancer Center ( Site 0008)	Matsuyama	Ehime
Japan	Shizuoka Cancer Center ( Site 0004)	Nagaizumi-cho,Sunto-gun	Shizuoka
Japan	Aichi Cancer Center Hospital ( Site 0018)	Nagoya	Aichi
Japan	Miyagi Cancer Center ( Site 0001)	Natori	Miyagi
Japan	Niigata Cancer Center Hospital ( Site 0017)	Niigata-shi	Niigata
Japan	Okayama University Hospital ( Site 0007)	Okayama
Japan	Kindai University Hospital- Osakasayama Campus ( Site 0013)	Osaka-sayama	Osaka
Japan	Sendai Kousei Hospital ( Site 0012)	Sendai	Miyagi
Japan	Takarazuka City Hospital ( Site 0015)	Takarazuka	Hyogo
Japan	Nippon Medical School Hospital ( Site 0003)	Tokyo
Japan	Wakayama Medical University Hospital ( Site 0006)	Wakayama
Japan	Kanagawa cancer center ( Site 0016)	Yokohama	Kanagawa
Korea, Republic of	Pusan National University Yangsan Hospital ( Site 0060)	Busan	Kyongsangnam-do
Korea, Republic of	Chungnam national university hospital-Department of Internal Medicine ( Site 0063)	Daejeon	Taejon-Kwangyokshi
Korea, Republic of	Chonnam National University Hwasun Hospital-Pulmonology ( Site 0061)	Hwasun	Jeonranamdo
Korea, Republic of	Asan Medical Center ( Site 0064)	Seoul
Korea, Republic of	Korea University Guro Hospital-Internal Medicine ( Site 0062)	Seoul
Latvia	Daugavpils Regional Hospital-Oncology Department ( Site 0194)	Daugavpils	Daugavpils Novads
Latvia	Liepjas reionl slimnca ( Site 0191)	Liepaja
Latvia	Pauls Stradins Clinical Univeristy Hospital-Chemotherapy department ( Site 0192)	Riga
Latvia	RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia-Out-patient and Day patient facility of Ch	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 0692)	Kaunas	Kauno Apskritis
Lithuania	National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 0691)	Vilnius	Vilniaus Miestas
Malaysia	Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 0034)	George Town	Pulau Pinang
Malaysia	Hospital Raja Perempuan Zainab II-Medical Department ( Site 0035)	Kota Bharu	Kelantan
Malaysia	Beacon Hospital Sdn Bhd ( Site 0033)	Petaling Jaya	Selangor
Peru	Clinica Vallesur - AUNA ( Site 0360)	Arequipa	Ariqipa
Peru	Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0362)	Concepcion	Junin
Peru	Clínica Internacional - Sede San Borja ( Site 0356)	Lima
Peru	Hospital Cayetano Heredia ( Site 0361)	Lima
Peru	Detecta Clínica ( Site 0364)	Surquillo	Lima
Peru	Centro de investigacion Clínica Trujillo ( Site 0358)	Trujillo	La Libertad
Philippines	Cebu Doctors University Hospital ( Site 0045)	Cebu
Philippines	Metro Davao Medical and Research Center ( Site 0047)	Davao City	Davao Del Sur
Philippines	ST. LUKE'S MEDICAL CENTER ( Site 0046)	Quezon City	National Capital Region
Poland	Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0208)	Bydgoszcz	Kujawsko-pomorskie
Poland	Med-Polonia Sp. z o. o. ( Site 0204)	Poznan	Wielkopolskie
Poland	Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 0202)	Prabuty	Pomorskie
Poland	Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0203)	Przemysl	Podkarpackie
Poland	Szpital Rejonowy im. dr. J. Rostka w Raciborzu ( Site 0207)	Racibórz	Slaskie
Poland	Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0201)	Siedlce	Mazowieckie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier	Warszawa	Mazowieckie
Romania	Gral Medical SRL-Medical Oncology ( Site 0220)	Bucure?ti	Bucuresti
Romania	Institutul Oncologic-Oncologie Medicala ( Site 0218)	Cluj
Romania	Cardiomed SRL Cluj-Napoca ( Site 0217)	Cluj-Napoca	Cluj
Romania	Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 0215)	Craiova	Dolj
Romania	Amethyst Radiotherapy Center-Oncologie Medicala ( Site 0216)	Flore?ti	Cluj
Romania	Cabinet Medical Oncomed ( Site 0219)	Timi?oara	Timis
Taiwan	E-Da hospital ( Site 0075)	Kaohsiung
Taiwan	Chung Shan Medical University Hospital ( Site 0078)	Taichung City	Taichung
Taiwan	National Cheng Kung University Hospital-Clinical Trial Center ( Site 0076)	Tainan
Taiwan	National Taiwan University Hospital-Internal Medicine ( Site 0080)	Taipei
Taiwan	National Taiwan University Cancer Center (NTUCC) ( Site 0079)	Taipei City	Taipei
Thailand	Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0097)	Bangkok	Krung Thep Maha Nakhon
Thailand	Faculty of Medicine Siriraj Hospital ( Site 0090)	Bangkok	Krung Thep Maha Nakhon
Thailand	Songklanagarind hospital ( Site 0091)	Hatyai	Songkhla
Thailand	Lampang Cancer Hospital ( Site 0098)	Lampang
Thailand	Maharaj Nakorn Chiang Mai Hospital ( Site 0092)	Muang	Chiang Mai
Thailand	Sunpasitthiprasong Hospital ( Site 0093)	Ubon Ratchathani
Turkey	Ankara City Hospital-Medical Oncology ( Site 0268)	Ankara
Turkey	Hacettepe Universite Hastaneleri-oncology hospital ( Site 0265)	Ankara
Turkey	Liv Hospital Ankara-Oncology ( Site 0274)	Ankara
Turkey	Trakya University-Medical Oncology ( Site 0270)	Edirne
Turkey	TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0267)	Istanbul
Turkey	VM Medical Park Pendik Hospital ( Site 0271)	Istanbul
Turkey	I.E.U. Medical Point Hastanesi-Oncology ( Site 0266)	Izmir, Karsiyaka	Izmir
Turkey	Mersin Sehir Egitim ve Arastirma Hastanesi ( Site 0275)	Mersin
United Kingdom	Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 0300)	Leicester	Leicestershire
United Kingdom	St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 0302)	London	London, City Of
United Kingdom	University College London Hospital ( Site 0305)	London	England
United Kingdom	The Clatterbridge Cancer Centre ( Site 0303)	Wirral
United States	Our Lady of the Lake RMC ( Site 0424)	Baton Rouge	Louisiana
United States	Clermont Oncology Center ( Site 0421)	Clermont	Florida
United States	Henry Ford Hospital ( Site 0412)	Detroit	Michigan
United States	Houston Methodist Hospital ( Site 0419)	Houston	Texas
United States	Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407)	Marietta	Georgia
United States	University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0417)	Miami	Florida
United States	Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0425)	Minneapolis	Minnesota
United States	Infirmary Cancer Care ( Site 0418)	Mobile	Alabama
United States	Mid Florida Hematology and Oncology Center ( Site 0416)	Orange City	Florida
United States	Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 0408)	Portland	Oregon
United States	Central Texas Veterans health care ( Site 0414)	Temple	Texas
United States	White Plains Hospital-Center for Cancer Care ( Site 0403)	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC	Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Chile,  China,  Estonia,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Peru,  Philippines,  Poland,  Romania,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 per the 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. RECIST 1.1 is modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS as assessed by blinded independent central review (BICR) will be presented.	Up to approximately 34 months
Primary	Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 48 months
Secondary	Objective Response (OR)	OR is defined as the confirmed 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 by BICR.	Up to approximately 34 months
Secondary	Duration of Response (DOR)	DOR is defined as the time from the first documented evidence of 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 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. Per RECIST 1.1, PD is defined as at least a 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.	Up to approximately 48 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)	The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "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?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.	Baseline and up to approximately 48 months
Secondary	Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30	The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better level of physical functioning. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.	Baseline and up to approximately 48 months
Secondary	Change from Baseline in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30	The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a better level of role functioning. Change from baseline in the role functioning (EORTC QLQ-C30 Items 6-7) combined score will be presented.	Baseline and up to approximately 48 months
Secondary	Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30	The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicates a worse level of dyspnea. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented.	Baseline and up to approximately 48 months
Secondary	Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13)	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?" will be 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. Higher scores indicate more frequent coughing and a worse outcome. The change from baseline in cough (EORTC QLQ-LC13 Item 31) score will be presented.	Baseline and up to approximately 48 months
Secondary	Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13	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. Higher scores indicate worse level of chest pain. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented.	Baseline and up to approximately 48 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	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?") will be scored on a 7-point scale (1=Very Poor to 7=Excellent). Higher scores indicate 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. TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented.	Up to approximately 48 months
Secondary	TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30	The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better level of physical functioning. 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. TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented.	Up to approximately 48 months
Secondary	TTD in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30	The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a better level of role functioning. 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. TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented.	Up to approximately 48 months
Secondary	TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 11	The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores 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. TTD in the score of EORTC QLQ-C30 Item 8 will be presented.	Up to approximately 48 months
Secondary	TTD in Cough Score (Item 31) on the EORTC QLQ-LC13	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?" will be 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. Higher scores indicate more frequent coughing and a worse 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. TTD in the score of EORTC QLQ-LC13 Item 31 will be presented.	Up to approximately 48 months
Secondary	TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13	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. Higher scores indicate 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. TTD in the score of EORTC QLQ-LC13 Item 40 will be presented.	Up to approximately 48 months
Secondary	Number of Participants Who Experience an Adverse Event (AE)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. Per protocol, the number of participants who experience an AE will be reported.	Up to approximately 48 months
Secondary	Number of Participants Who Discontinue Study Treatment Due To an AE	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. Per protocol, the number of participants who discontinue study treatment due to an AE will be reported.	Up to approximately 48 months

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary