Lung Neoplasms Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-Blind Study of MK-7684 With Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer
The primary hypotheses are that coformulated pembrolizumab/vibostolimab is superior to pembrolizumab alone with respect to (1) overall survival (OS) in participants with programmed cell death 1 ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%, TPS ≥1% and TPS 1% to 49%; and (2) progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR), in participants with PD-L1 TPS ≥1% and TPS ≥50%.
| Status | Recruiting |
| Enrollment | 1246 |
| Est. completion date | June 5, 2028 |
| Est. primary completion date | April 21, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8 - Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment - Has confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy and absence of ALK and ROS1 gene rearrangements - Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in =1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory - Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 assessed within 7 days prior to randomization - Has a life expectancy of at least 3 months - A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: - Is not a woman of childbearing potential (WOCBP) - Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention - Has adequate organ function Exclusion Criteria: - 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 at least 3 years since initiation of that therapy - Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. - Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 6 months before the diagnosis of metastatic NSCLC. - Participants must have recovered from all AEs due to previous therapies to Grade =1 or baseline. Participants with Grade =2 neuropathy may be eligible. Participants with endocrine-related AEs Grade =2 requiring treatment or hormone replacement may be eligible. - Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137) - Has received previous treatment with another agent targeting the T cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibition motif (ITIM) domains (TIGIT) receptor pathway - Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-central nervous system (CNS) disease - Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed. - Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy. - Investigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed. - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention - Has known active or untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention - Has severe hypersensitivity (=Grade 3) to pembrolizumab/vibostolimab or pembrolizumab and/or any of its excipients - Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. - Has a 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 prior to the first dose of study intervention - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis - Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary. - Has an active infection requiring systemic therapy - Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority - Has a known history of Hepatitis B or known active Hepatitis C virus infection - Has a history or current evidence of any condition, therapy, or laboratory abnormality that prevents the participant from receiving platinum-doublet chemotherapy for first line NSCLC, or that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. - Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0209) | Florianópolis | Santa Catarina |
| Brazil | Hospital São Carlos-Oncocentro Ce ( Site 0208) | Fortaleza | Ceara |
| Brazil | ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206) | Ijui | Rio Grande Do Sul |
| Brazil | Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0201) | Natal | Rio Grande Do Norte |
| Brazil | Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa Novos Tratamentos em Cân | Porto Alegre | Rio Grande Do Sul |
| Brazil | Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0204) | Rio de Janeiro | |
| Brazil | Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0207) | Sao Paulo | |
| Brazil | ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0200) | São Paulo | Sao Paulo |
| Canada | Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0104) | Hamilton | Ontario |
| Canada | Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0102) | Kingston | Ontario |
| Canada | Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de Lava | Laval | Quebec |
| Canada | Lakeridge Health ( Site 0106) | Oshawa | Ontario |
| Canada | BC Cancer Victoria-Clinical Trials Unit ( Site 0107) | Victoria | British Columbia |
| Chile | Bradford Hill Norte ( Site 0708) | Antofagasta | |
| Chile | IC La Serena Research ( Site 0710) | La Serena | Coquimbo |
| Chile | FALP ( Site 0702) | Providencia | Region M. De Santiago |
| Chile | Clínica Puerto Montt ( Site 0713) | Puerto Montt | Los Lagos |
| Chile | Bradfordhill ( Site 0701) | Santiago | Region M. De Santiago |
| Chile | Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0712) | Santiago | Region M. De Santiago |
| Chile | Orlandi Oncologia ( Site 0700) | Santiago | Region M. De Santiago |
| Chile | Clinica Universidad Catolica del Maule-Oncology ( Site 0703) | Talca | Maule |
| Chile | CIDO SpA-Oncology ( Site 0707) | Temuco | Araucania |
| Chile | James Lind Centro de Investigación del Cáncer ( Site 0711) | Temuco | Araucania |
| Chile | Oncocentro Valdivia ( Site 0715) | Valdivia | Los Rios |
| China | Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2001) | Beijing | Beijing |
| China | Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2003) | Beijing | Beijing |
| China | Beijing Chest Hospital,Capital Medical University ( Site 2020) | Beijing | Beijing |
| China | Beijing Peking Union Medical College Hospital-pneumology department ( Site 2009) | Beijing | Beijing |
| China | Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 2030) | Beijing | Beijing |
| China | Jilin Cancer Hospital-oncology department ( Site 2000) | Changchun | Jilin |
| China | Hunan Cancer Hospital-thoracic oncology II ( Site 2013) | Changsha | Hunan |
| China | Xiangya Hospital Central South University-Respiratory -Asthma&COPD ( Site 2026) | Changsha | Hunan |
| China | West China Hospital Sichuan University-respiratory ( Site 2018) | Cheng Du | Sichuan |
| China | Army Medical Center of People's Liberation Army-respiratory ( Site 2025) | Chongqing | Chongqing |
| China | Chongqing Cancer Hospital-Medical Oncology ( Site 2028) | Chongqing | Chongqing |
| China | Fujian Provincial Cancer Hospital-oncology department ( Site 2023) | Fuzhou | Fujian |
| China | Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 2029) | Fuzhou | Fujian |
| China | Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( | Guangzhou | Guangdong |
| China | Hangzhou Cancer Hospital-Medical Oncology ( Site 2039) | Hangzhou | Zhejiang |
| China | The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site | Hangzhou | Zhejiang |
| China | The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site | Hangzhou | Zhejiang |
| China | Zhejiang Cancer Hospital-Breast Oncology ( Site 2008) | Hangzhou | Zhejiang |
| China | Harbin Medical University Cancer Hospital ( Site 2006) | Harbin | Heilongjiang |
| China | Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2017) | Hefei | Anhui |
| China | The First Affiliated Hospital of Anhui Medical University ( Site 2022) | Hefei | Anhui |
| China | Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2027) | Linhai | Zhejiang |
| China | LinYi Cancer Hospital ( Site 2034) | Linyi | Shandong |
| China | Linyi People's Hospital-Oncology ( Site 2035) | Linyi | Shandong |
| China | Fudan University Shanghai Cancer Center ( Site 2032) | Shanghai | Shanghai |
| China | The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2031) | Wenzhou | Zhejiang |
| China | Wuhan Union Hospital-Medical Oncology ( Site 2019) | Wuhan | Hubei |
| China | Tang Du Hospital ( Site 2004) | Xi'an | Shaanxi |
| China | The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2012) | Xi'an | Shaanxi |
| China | Northern Jiangsu People's Hospital-General Surgery Department ( Site 2016) | Yangzhou | Jiangsu |
| China | Henan Cancer Hospital ( Site 2015) | Zhengzhou | Henan |
| Dominican Republic | CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 2301) | Santo Domingo | Distrito Nacional |
| Dominican Republic | Instituto de Oncologia ( Site 2300) | Santo Domingo | Distrito Nacional |
| Guatemala | CELAN,S.A ( Site 0304) | Guatemala | |
| Guatemala | Gastrosoluciones ( Site 0302) | Guatemala | |
| Guatemala | Grupo Medico Angeles ( Site 3007) | Guatemala | |
| Guatemala | INTEGRA Cancer Institute ( Site 0303) | Guatemala | |
| Guatemala | Oncomedica-Guatemala ( Site 0301) | Guatemala | |
| Guatemala | Onco Go, S.A ( Site 0306) | Guatemala City | |
| Hong Kong | Hong Kong Integrated Oncology Centre ( Site 1301) | Central | |
| Hong Kong | Queen Mary Hospital ( Site 1303) | Hksar | |
| Hong Kong | Hong Kong United Oncology Centre ( Site 1302) | Jordan | |
| Hong Kong | Princess Margaret Hospital ( Site 1304) | Lai Chi Kok | |
| Hungary | Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 1204) | Budapest | Pest |
| Hungary | Semmelweis University-Pulmonológiai Klinika ( Site 1209) | Budapest | |
| Hungary | Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia ( Site 1205) | Gyor | Gyor-Moson-Sopron |
| Hungary | Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 1207) | Gyula | Bekes |
| Hungary | Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1201) | Kecskemét | Bacs-Kiskun |
| Hungary | Mátrai Gyógyintézet ( Site 1214) | Kékesteto | Heves |
| Hungary | Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1200) | Szolnok | Jasz-Nagykun-Szolnok |
| Hungary | Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1208) | Torokbalint | Pest |
| Hungary | Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 1202) | Zalaegerszeg | Zala |
| India | Artemis hospital ( Site 2401) | Gurugram | Haryana |
| India | All India Institute of Medical Sciences ( Site 2403) | New Delhi | Delhi |
| India | Rajiv Gandhi Cancer Institute And Research Centre ( Site 2400) | New Delhi | Delhi |
| Japan | Chiba University Hospital-Medical Oncology ( Site 1926) | Chiba | |
| Japan | Kansai Medical University Hospital ( Site 1914) | Hirakata | Osaka |
| Japan | Kurume University Hospital ( Site 1912) | Kurume | Fukuoka |
| Japan | Shizuoka Cancer Center ( Site 1905) | Nagaizumi | Shizuoka |
| Japan | National Hospital Organization Nagoya Medical Center ( Site 1920) | Nagoya | Aichi |
| Japan | Niigata Cancer Center Hospital ( Site 1904) | Niigata-shi | Niigata |
| Japan | Hyogo College of Medicine-Respiratory Medicine and Hematology ( Site 1922) | Nishinomiya | Hyogo |
| Japan | Okayama University Hospital ( Site 1913) | Okayama | |
| Japan | Osaka International Cancer Institute ( Site 1915) | Osaka | |
| Japan | Kindai University Hospital- Osakasayama Campus ( Site 1907) | Osaka-sayama | Osaka |
| Japan | Gunma Prefectural Cancer Center ( Site 1925) | Otashi | Gunma |
| Japan | National Hospital Organization Kinki-chuo Chest Medical Center-Department of Thoracic Oncology ( Sit | Sakai | Osaka |
| Japan | National Hospital Organization Hokkaido Cancer Center ( Site 1923) | Sapporo | Hokkaido |
| Japan | Sendai Kousei Hospital ( Site 1900) | Sendai | Miyagi |
| Japan | Takarazuka City Hospital ( Site 1924) | Takarazuka | Hyogo |
| Japan | Osaka Medical and Pharmaceutical University Hospital ( Site 1908) | Takatsuki | Osaka |
| Japan | Tokushima University Hospital ( Site 1917) | Tokushima | |
| Japan | Japanese Foundation for Cancer Research ( Site 1901) | Tokyo | |
| Japan | Juntendo University Hospital ( Site 1902) | Tokyo | |
| Japan | Ehime University Hospital ( Site 1911) | Toon | Ehime |
| Japan | Fujita Health University ( Site 1906) | Toyoake | Aichi |
| Japan | Tochigi Cancer Center ( Site 1927) | Utsunomiya | Tochigi |
| Japan | Wakayama Medical University Hospital ( Site 1910) | Wakayama | |
| Japan | Kanagawa cancer center ( Site 1916) | Yokohama | Kanagawa |
| Japan | Kanagawa Cardiovascular and Respiratory Center ( Site 1921) | Yokohama | Kanagawa |
| Korea, Republic of | Chungbuk National University Hospital-Internal medicine ( Site 1406) | Cheongju-si | Chungbuk |
| Korea, Republic of | National Cancer Center-Lung Cancer Center ( Site 1407) | Goyang-si | Kyonggi-do |
| Korea, Republic of | Seoul National University Bundang Hospital ( Site 1403) | Seongnam | Kyonggi-do |
| Korea, Republic of | Asan Medical Center ( Site 1400) | Seoul | |
| Korea, Republic of | Kangbuk Samsung Hospital ( Site 1409) | Seoul | |
| Korea, Republic of | Seoul National University Hospital ( Site 1401) | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System ( Site 1402) | Seoul | |
| Korea, Republic of | The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1408) | Seoul | |
| Korea, Republic of | The Catholic University of Korea, Eunpyeong St. Mary's Hospital-Cancer center ( Site 1410) | Seoul | |
| Korea, Republic of | The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1405) | Suwon-si | Kyonggi-do |
| Malaysia | Gleneagles Penang Medical Center-Clinical Research Center (CRC) ( Site 1503) | George Town | Pulau Pinang |
| Malaysia | Hospital Pulau Pinang ( Site 1501) | George Town | Pulau Pinang |
| Malaysia | Hospital Tengku Ampuan Afzan ( Site 1502) | Kuantan | Pahang |
| Malaysia | University Malaya Medical Centre ( Site 1504) | Lembah Pantai | Kuala Lumpur |
| Malaysia | National Cancer Institute ( Site 1505) | Putrajaya | Wilayah Persekutuan Putrajaya |
| Mexico | Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 0402) | Chihuahua | |
| Mexico | Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0411) | Guadalajara | Jalisco |
| Mexico | Medical Care and Research SA de CV ( Site 0409) | Merida | Yucatan |
| Mexico | Arké SMO S.A. de C.V. ( Site 0417) | Mexico | Distrito Federal |
| Mexico | Human Science Research Trials ( Site 0406) | Mexico city | |
| Mexico | iCan Oncology Center Centro Medico AVE ( Site 0405) | Monterrey | Nuevo Leon |
| Mexico | Centro de Investigacion Clinica Chapultepec ( Site 0400) | Morelia | Michoacan |
| Mexico | Oaxaca Site Management Organization ( Site 0403) | Oaxaca | |
| Mexico | Hospital H+ Queretaro ( Site 0416) | Santiago de Queretaro | Queretaro |
| Peru | UNIDAD DE ONCOLOGIA HOSPITAL NACIONAL ADOLFO GUEVARA VELASCO ESSSALUD CUSCO ( Site 0504) | Cusco | Qusqu |
| Peru | Clínica Internacional - Sede San Borja ( Site 0506) | Lima | |
| Peru | Hospital Guillermo Almenara Irigoyen-Oncology ( Site 0508) | Lima | |
| Peru | Hospital Militar Central Luis Arias Schereiber ( Site 0502) | Lima | |
| Peru | INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0500) | Lima | |
| Peru | IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0507) | Lima | |
| Philippines | East Avenue Medical Center-Department of Medicine ( Site 1605) | Quezon City | National Capital Region |
| Philippines | Veterans Memorial Medical Center-Section of Oncology ( Site 1608) | Quezon City | National Capital Region |
| Philippines | CARDINAL SANTOS MEDICAL CENTER ( Site 1606) | San Juan City, Metro Manila | National Capital Region |
| Romania | Cardiomed SRL Cluj-Napoca ( Site 2201) | Cluj-Napoca | Cluj |
| Romania | Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2202) | Craiova | Dolj |
| Romania | SC Medical Center Gral SRL ( Site 2203) | Ploiesti | Prahova |
| Russian Federation | Moscow Regional Oncological Dispensary ( Site 0812) | Balashikha | Moskovskaya Oblast |
| Russian Federation | Republican Clinical Oncology Dispensary ( Site 0805) | Kazan | Tatarstan, Respublika |
| Russian Federation | Central Clinical Hospital of the Presidential Administrative Department ( Site 0802) | Moscow | Moskva |
| Russian Federation | Hadassah Medical-Oncology department ( Site 0814) | Moscow | Moskovskaya Oblast |
| Russian Federation | Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 0809) | Nizhniy Novgorod | Nizhegorodskaya Oblast |
| Russian Federation | GBUZ LOKB-Oncology department #1 ( Site 0804) | Saint-Petersburg | Sankt-Peterburg |
| Russian Federation | Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 0803) | Sankt-Peterburg | |
| South Africa | Cape Town Oncology Trials ( Site 0903) | Cape Town | Western Cape |
| South Africa | The Oncology Centre ( Site 0905) | Durban | Kwazulu-Natal |
| South Africa | Medical Oncology Centre of Rosebank ( Site 0906) | Johannesburg | Gauteng |
| South Africa | Wits Clinical Research ( Site 0900) | Johannesburg | Gauteng |
| South Africa | LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0901) | Pretoria | Gauteng |
| South Africa | Abraham Oncology ( Site 0907) | Richards Bay | Kwazulu-Natal |
| South Africa | Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0902) | Sandton | Gauteng |
| South Africa | Wits Clinical Research-Wits Clinical Research Bara ( Site 0908) | Soweto | Gauteng |
| Taiwan | Changhua Christian Hospital ( Site 1711) | Changhua County | Changhua |
| Taiwan | National Taiwan University Hospital - Hsinchu branch ( Site 1704) | Hsinchu | |
| Taiwan | Chang Gung Memorial Hospital at Kaohsiung ( Site 1702) | Kaohsiung Niao Sung Dist | Kaohsiung |
| Taiwan | Taichung Veterans General Hospital-Chest ( Site 1707) | Taichung | |
| Taiwan | NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1705) | Tainan | |
| Taiwan | Mackay Memorial Hospital-Chest Medicine ( Site 1703) | Taipei | |
| Taiwan | National Taiwan University Hospital-Oncology ( Site 1706) | Taipei | |
| Taiwan | Taipei Medical University Hospital ( Site 1712) | Taipei | |
| Taiwan | Taipei Veterans General Hospital ( Site 1709) | Taipei | |
| Taiwan | Tri-Service General Hospital-hematology&oncology ( Site 1710) | Taipei City | Taipei |
| Taiwan | Chang Gung Medical Foundation-Linkou Branch ( Site 1708) | Taoyuan | |
| Thailand | Chulalongkorn University ( Site 1802) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Faculty of Medicine Siriraj Hospital ( Site 1800) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Ramathibodi Clinical Research Centre ( Site 1801) | Bangkok | Krung Thep Maha Nakhon |
| Turkey | Gazi Universitesi-Oncology ( Site 1003) | Ankara | |
| Turkey | Hacettepe Universitesi-oncology hospital ( Site 1001) | Ankara | |
| Turkey | Memorial Ankara Hastanesi-Medical Oncology ( Site 1002) | Ankara | |
| Turkey | Acibadem Maslak Hastanesi ( Site 1008) | Istanbul | |
| Turkey | Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1000) | Istanbul | |
| Turkey | Samsun Medical Park Hastanesi-medical oncology ( Site 1005) | Samsun | |
| Turkey | Erciyes University Medical Oncology Department ( Site 1007) | Talas | Kayseri |
| Ukraine | Cherkasy Regional Oncology Dispensary ( Site 1110) | Cherkassy | Cherkaska Oblast |
| Ukraine | Chernihiv Medical Center of Modern Oncology-Clinical oncology and gynecology department ( Site 1113) | Chernihiv | Chernihivska Oblast |
| Ukraine | Municipal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council ( Site 1100) | Dnipro | Dnipropetrovska Oblast |
| Ukraine | Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio | Ivano-Frankivsk | Ivano-Frankivska Oblast |
| Ukraine | Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1119) | Kharkiv | Kharkivska Oblast |
| Ukraine | MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 1104) | Kryvyi Rih | Dnipropetrovska Oblast |
| Ukraine | National Cancer Institute ( Site 1114) | Kyiv | Kyivska Oblast |
| Ukraine | Uzhgorod Central City Clinical Hospital-City oncology center ( Site 1120) | Uzhhorod | Zakarpatska Oblast |
| Ukraine | Vinnytsia Regional Clinical Oncological Hospital ( Site 1102) | Vinnytsia | Vinnytska Oblast |
| Ukraine | Oncolife LLC-day-stay department ( Site 1107) | Zaporizhzhia | Zaporizka Oblast |
| Ukraine | Zhytomyr Regional Oncology Center-Chemotherapy Department ( Site 1103) | Zhytomyr | Zhytomyrska Oblast |
| United States | Boca Raton Regional Hospital ( Site 0004) | Boca Raton | Florida |
| United States | Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0022) | Mineola | New York |
| United States | Memorial Sloan Kettering Cancer Center ( Site 0013) | New York | New York |
| United States | Illinois Cancer Care ( Site 0026) | Peoria | Illinois |
| United States | Fox Chase Cancer Center-Hematology/Oncology ( Site 0030) | Philadelphia | Pennsylvania |
| United States | Mercy Research - David C. Pratt Cancer Center ( Site 0025) | Saint Louis | Missouri |
| United States | Mercy Research - Cancer and Hematology Center ( Site 0032) | Springfield | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Brazil, Canada, Chile, China, Dominican Republic, Guatemala, Hong Kong, Hungary, India, Japan, Korea, Republic of, Malaysia, Mexico, Peru, Philippines, Romania, Russian Federation, South Africa, Taiwan, Thailand, Turkey, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =50% | OS is defined as the time from randomization to death due to any cause. | Up to ~59 months | |
| Primary | OS in Participants With PD-L1 TPS =1% | OS is defined as the time from randomization to death due to any cause. | Up to ~59 months | |
| Primary | OS in Participants With PD-L1 TPS 1% to 49% | OS is defined as the time from randomization to death due to any cause. | Up to ~59 months | |
| Primary | Progression-Free Survival (PFS) in Participants With PD-L1 TPS =1% | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (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 will be presented. | Up to ~51 months | |
| Primary | PFS in Participants With PD-L1 TPS =50% | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (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 will be presented. | Up to ~51 months | |
| Secondary | Objective Response Rate (ORR) in Participants With PD-L1 TPS =1% | ORR is defined as the percentage of participants 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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. | Up to ~ 2 years | |
| Secondary | PFS in Participants With PD-L1 TPS 1% to 49% | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (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 will be presented. | Up to ~51 months | |
| Secondary | ORR in Participants With PD-L1 TPS =50% | ORR is defined as the percentage of participants 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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. | Up to ~ 2 years | |
| Secondary | ORR in Participants With PD-L1 TPS 1% to 49% | ORR is defined as the percentage of participants 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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. | Up to ~ 2 years | |
| Secondary | Duration of Response (DOR) in Participants With PD-L1 TPS =50% | 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 ~59 months | |
| Secondary | DOR in Participants With PD-L1 TPS 1% to 49% | 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 ~59 months | |
| Secondary | DOR in Participants With PD-L1 TPS =1% | 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 ~59 months | |
| Secondary | Change from Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) in Participants With PD-L1 TPS =50% | 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 ~107 weeks | |
| Secondary | Change from Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | 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 ~107 weeks | |
| Secondary | Change from Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS =1% | 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 ~107 weeks | |
| Secondary | Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS =50% | 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 ~107 weeks | |
| Secondary | Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | 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 ~107 weeks | |
| Secondary | Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS =1% | 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 ~107 weeks | |
| Secondary | Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS =50% | 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 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 ~107 weeks | |
| Secondary | Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | 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 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 ~107 weeks | |
| Secondary | Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS =1% | 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 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 ~107 weeks | |
| Secondary | Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS =50% | 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 ~107 weeks | |
| Secondary | Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | 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 ~107 weeks | |
| Secondary | Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS =1% | 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 ~107 weeks | |
| 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) in Participants With PD-L1 TPS =50% | 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 ~107 weeks | |
| Secondary | Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% | 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 ~107 weeks | |
| Secondary | Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS =1% | 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 ~107 weeks | |
| Secondary | Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS =50% | 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 ~107 weeks | |
| Secondary | Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% | 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 ~107 weeks | |
| Secondary | Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS =1% | 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 ~107 weeks | |
| Secondary | Time to Deterioration (TTD) in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS =50% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS =1% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS =50% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS =1% to 49% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS =1% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS =50% | 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 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | 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 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS =1% | 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 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS =50% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS =1% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS =50% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS =1% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS =50% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% | 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. | Baseline and up to ~107 weeks | |
| Secondary | TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS =1% | 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. | Baseline and up to ~107 weeks | |
| 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 ~115 weeks | |
| Secondary | Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (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 ~103 weeks |
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