Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006) (KEYVIBE-006)

Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC

Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab.

Study Overview

• Status: Active, not recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Biological: pembrolizumab/vibostolimab; Biological: durvalumab; Drug: cisplatin; Drug: pemetrexed; Drug: etoposide; Drug: carboplatin; Drug: paclitaxel; Radiation: thoracic radiotherapy

Detailed Description

As of protocol amendment 4, participants receiving combination vibostolimab and pembrolizumab (MK-7684A) discontinued treatment due to lack of efficacy observed in other MK-7684A studies, and are given the option to transition to durvalumab therapy.

• Study Type: Interventional
• Enrollment (Actual): 611
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba
    • Caba., Caba, Argentina, C1430EGF
      • Clinica Adventista Belgrano ( Site 3601)
  • Cordoba
    • Rio Cuarto, Cordoba, Argentina, X5800
      • Instituto Médico Río Cuarto ( Site 3600)
  • Santa Fe
    • Rosario., Santa Fe, Argentina, S2000DSV
      • Sanatorio Parque ( Site 3602)
• Australia
  • Australian Capital Territory
    • Canberra, Australian Capital Territory, Australia, 2605
      • Canberra Hospital ( Site 0010)
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Icon Cancer Centre Hobart ( Site 0003)
  • Victoria
    • Ballarat Central, Victoria, Australia, 3350
      • Ballarat Health Services-Medical Oncology ( Site 0002)
    • Frankston, Victoria, Australia, 3199
      • Frankston Hospital-Oncology and Haematology ( Site 0009)
    • Melbourne, Victoria, Australia, 3065
      • St Vincent's Hospital-Oncology Clinical Trials ( Site 0005)
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0105)
  • Sao Paulo, Brazil, 01509-010
    • A. C. Camargo Cancer Center-CAPEC ( Site 0102)
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora da Conceição ( Site 0111)
• Chile
  • Araucania
    • Temuco, Araucania, Chile, 4800827
      • James Lind Centro de Investigacion del Cancer ( Site 0202)
  • Biobio
    • Concepcion., Biobio, Chile, 4070196
      • Biocenter ( Site 0208)
  • Region M. De Santiago
    • Santiago, Region M. De Santiago, Chile, 8420383
      • Bradfordhill ( Site 0200)
    • Santiago, Region M. De Santiago, Chile, 7500921
      • FALP-UIDO ( Site 0205)
    • Santiago, Region M. De Santiago, Chile, 7560908
      • Centro de Oncología de Precisión ( Site 0209)
  • Valparaiso
    • Viña del Mar, Valparaiso, Chile, 2520598
      • ONCOCENTRO APYS-ACEREY ( Site 0203)
• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer hospital-intrathoratic deparmtment II ( Site 0328)
    • Beijing, Beijing, China, 100142
      • Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 0309)
    • Beijing, Beijing, China, 100730
      • Beijing Peking Union Medical College Hospital-pneumology department ( Site 0300)
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Army Medical Center of People's Liberation Army-Oncology Department ( Site 0321)
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Provincial Cancer Hospital ( Site 0316)
    • Fuzhou Fujian, Fujian, China, 350001
      • Fujian Medical University Union Hospital-1 Bingfanglou ( Site 0330)
    • Xiamen, Fujian, China, 361003
      • The First Affiliated hospital of Xiamen University-oncology ( Site 0317)
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Southern Medical University Nanfang Hospital-Department of Oncology ( Site 0336)
  • Hebei
    • Shijiazhuang, Hebei, China, 050035
      • Fourth Hospital of Hebei Medical University ( Site 0331)
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital ( Site 0333)
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital ( Site 0311)
    • Wuhan, Hubei, China, 430000
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0315)
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University-Oncology department ( Site 0310)
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital ( Site 0307)
  • Jiangsu
    • Suzhou, Jiangsu, China, 215004
      • The Second Affiliated Hospital of Soochow University ( Site 0314)
    • Zhenjiang, Jiangsu, China, 212001
      • Affiliated Hospital of Jiangsu University ( Site 0305)
  • Jilin
    • Changchun, Jilin, China, 130012
      • Jilin Cancer Hospital-oncology department ( Site 0319)
  • Shandong
    • Jinan, Shandong, China, 250001
      • Shandong Provincial Hospital ( Site 0326)
    • Qingdao, Shandong, China, 266042
      • Qingdao Central Hospital-Endocrinology ( Site 0332)
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital-Radiotherapy Department ( Site 0306)
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center ( Site 0304)
    • Shanghai, Shanghai, China, 200433
      • Shanghai Pulmonary Hospital-Radiotherapy department ( Site 0335)
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Cancer Hospital-Pulmonology ( Site 0322)
  • Sichuan
    • Cheng Du, Sichuan, China, 610041
      • West China Hospital of Sichuan University ( Site 0324)
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Cancer Hospital ( Site 0329)
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310002
      • Hangzhou Cancer Hospital-Medical Oncology ( Site 0302)
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0301)
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital ( Site 0308)
• Costa Rica
  • San Jose
    • San José, San Jose, Costa Rica, 10103
      • CIMCA ( Site 0501)
    • San José, San Jose, Costa Rica, 11303
      • PROCLINICAL Pharma ( Site 0504)
    • Santa Ana, San Jose, Costa Rica, 10903
      • Hospital Metropolitano - Sede Lindora ( Site 0503)
• Czechia
  • Brno-mesto
    • Brno, Brno-mesto, Czechia, 656 53
      • Masarykuv onkologicky ustav ( Site 3500)
  • Moravskoslezsky Kraj
    • Ostrava, Moravskoslezsky Kraj, Czechia, 708 52
      • Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 3502)
• Dominican Republic
  • Distrito Nacional
    • Santo Domingo, Distrito Nacional, Dominican Republic, 10102
      • Instituto de Oncologia ( Site 3003)
  • Santo Domingo
    • Distrito Nacional, Santo Domingo, Dominican Republic, 10148
      • Onconet ( Site 3002)
• Germany
  • Berlin, Germany, 13353
    • Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0603)
  • Sachsen
    • Chemnitz, Sachsen, Germany, 09116
      • Klinikum Chemnitz-Klinik für Innere Medizin IV ( Site 0607)
  • Schleswig-Holstein
    • Grosshansdorf, Schleswig-Holstein, Germany, 22927
      • LungenClinic Grosshansdorf-Onkologie ( Site 0602)
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein Campus Kiel-Medizinische Klinik II, Hämatologie und Onkolo ( Site 0609)
• Greece
  • Thessaloniki, Greece, 570 01
    • European Interbalkan Medical Center ( Site 0701)
  • Attiki
    • Athens, Attiki, Greece, 115 26
      • Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 0703)
    • Athens, Attiki, Greece, 115 28
      • Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0706)
    • Athens, Attiki, Greece, 11527
      • Sotiria Thoracic Diseases Hospital of Athens ( Site 0704)
    • Athens, Attiki, Greece, 185 47
      • Metropolitan Hospital ( Site 0702)
    • Nea Kifissia, Attiki, Greece, 136 77
      • General Oncology Hospital of Kifissia "Agioi Anargiroi"-2nd Department of Medical Oncology ( Site 0705)
  • Irakleio
    • Heraklion, Irakleio, Greece, 715 00
      • University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0700)
• Guatemala
  • Ciudad de Guatemala, Guatemala, 01010
    • Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0802)
  • Guatemala, Guatemala, 01009
    • MEDI-K ( Site 0807)
  • Quetzaltenango, Guatemala, 09001
    • Centro Regional de Sub Especialidades Médicas SA ( Site 0801)
  • Quetzaltenango, Guatemala, 09002
    • Centro Medico Integral De Cancerología (CEMIC) ( Site 0805)
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus-Oncology ( Site 1001)
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center ( Site 1003)
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center ( Site 1004)
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center-ONCOLOGY ( Site 1000)
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center ( Site 1002)
• Italy
  • Brescia, Italy, 25123
    • Azienda Ospedaliera Spedali Civili di Brescia ( Site 1105)
  • Milano, Italy, 20132
    • Ospedale San Raffaele. ( Site 1104)
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo ( Site 1103)
  • Campania
    • Napoli, Campania, Italy, 80131
      • Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia medica Toraco-Polmonare ( Site 1107)
  • Lazio
    • Roma, Lazio, Italy, 00128
      • Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 1101)
  • Lombardia
    • Milan, Lombardia, Italy, 20133
      • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1100)
    • Monza, Lombardia, Italy, 20900
      • Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1102)
• Japan
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute ( Site 1209)
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center ( Site 1211)
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital ( Site 1212)
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0046
      • Kobe Minimally Invasive Cancer Center ( Site 1210)
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
      • Kanagawa Cancer Center ( Site 1204)
  • Miyagi
    • Natori, Miyagi, Japan, 981-1293
      • Miyagi Cancer Center ( Site 1200)
    • Sendai, Miyagi, Japan, 981-0914
      • Sendai Kousei Hospital ( Site 1213)
  • Niigata
    • Niigata-shi, Niigata, Japan, 951-8566
      • Niigata Cancer Center Hospital ( Site 1205)
  • Osaka
    • Hirakata, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital ( Site 1207)
    • Takatsuki, Osaka, Japan, 569-8686
      • Osaka Medical and Pharmaceutical University Hospital ( Site 1208)
  • Saitama
    • Ina-machi, Saitama, Japan, 362-0806
      • Saitama Prefectural Cancer Center ( Site 1201)
  • Tokyo
    • Koto, Tokyo, Japan, 135-8550
      • Cancer Institute Hospital of JFCR ( Site 1202)
    • Shinagawa, Tokyo, Japan, 142-8666
      • Showa Medical University Hospital ( Site 1203)
• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 2403)
  • Chungbuk
    • Cheongju-si, Chungbuk, Korea, Republic of, 28644
      • Chungbuk National University Hospital-Internal medicine ( Site 2400)
  • Kyonggi-do
    • Suwon-si, Kyonggi-do, Korea, Republic of, 16247
      • The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2401)
    • Suwon-si, Kyonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital-Hematology-Oncology ( Site 2402)
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1401)
  • Kuala Lumpur
    • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
      • University Malaya Medical Centre-Clinical Oncology ( Site 1402)
  • Pulau Pinang
    • George Town, Pulau Pinang, Malaysia, 10450
      • Hospital Pulau Pinang ( Site 1400)
• Mexico
  • Chihuahua, Mexico, 31217
    • Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 1507)
  • Oaxaca, Mexico, 68020
    • Centro de Investigacion Clinica de Oaxaca ( Site 1501)
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 06700
      • Arké SMO S.A. de C.V. ( Site 1504)
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44680
      • Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 1505)
• Philippines
  • National Capital Region
    • Pasig, National Capital Region, Philippines, 1605
      • THE MEDICAL CITY-Cancer Research Center ( Site 3200)
    • Quezon City, National Capital Region, Philippines, 1100
      • Veterans Memorial Medical Center-Section of Oncology ( Site 3201)
• Portugal
  • Porto, Portugal, 4099-001
    • Unidade Local de Saude de Santo António - Hospital Santo António ( Site 2004)
  • Porto, Portugal, 4200-072
    • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2001)
  • Lisboa
    • Lisbon, Lisboa, Portugal, 1400-038
      • Champalimaud Foundation ( Site 2003)
    • Lisbon, Lisboa, Portugal, 1998-018
      • Hospital CUF Descobertas ( Site 2006)
• Romania
  • Bucuresti, Romania, 077190
    • Centrul Medical Neolife- Baneasa ( Site 2110)
  • Bucuresti
    • Bucharest, Bucuresti, Romania, 010626
      • Centrul Medical Medicover Victoria ( Site 2106)
  • Cluj
    • Florești, Cluj, Romania, 407280
      • Amethyst Radiotherapy Center ( Site 2102)
  • Dolj
    • Craiova, Dolj, Romania, 200542
      • Centrul de Oncologie "Sfântul Nectarie" ( Site 2100)
  • Ilfov
    • Otopeni, Ilfov, Romania, 075100
      • Radiology Therapeutic Center ( Site 2108)
  • Timis
    • Timisoara, Timis, Romania, 300239
      • Cabinet Medical Oncomed ( Site 2101)
• South Africa
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa, 6055
      • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2304)
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0040
      • Wilgers Oncology Centre ( Site 2301)
  • Kwazulu-Natal
    • Durban, Kwazulu-Natal, South Africa, 4091
      • The Oncology Centre ( Site 2300)
    • Richards Bay, Kwazulu-Natal, South Africa, 3900
      • Abraham Oncology ( Site 2303)
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7570
      • Cape Town Oncology Trials ( Site 2306)
• Spain
  • Cataluna
    • Barcelona, Cataluna, Spain, 08035
      • Hospital Universitari Vall d'Hebron ( Site 2501)
    • Barcelona, Cataluna, Spain, 08036
      • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2503)
  • La Coruna
    • Santiago de Compostela, La Coruna, Spain, 15706
      • CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2502)
  • Madrid, Comunidad De
    • Pozuelo de Alarcon, Madrid, Comunidad De, Spain, 28223
      • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2504)
• Turkey
  • Adana, Turkey, 01250
    • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2607)
  • Ankara, Turkey, 06010
    • Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 2602)
  • Ankara, Turkey, 06230
    • Hacettepe Universitesi-oncology hospital ( Site 2605)
  • Ankara, Turkey, 06520
    • Memorial Ankara Hastanesi-Medical Oncology ( Site 2609)
  • Ankara, Turkey, 06800
    • Ankara City Hospital-Medical Oncology ( Site 2601)
  • Istanbul, Turkey, 34722
    • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2610)
  • Izmir, Turkey, 35575
    • I.E.U. Medical Point Hastanesi-Oncology ( Site 2612)
  • Istanbul
    • Stanbul, Istanbul, Turkey, 34214
      • Medipol Mega Universite Hastanesi-oncology ( Site 2611)
  • Izmir
    • Bornova, Izmir, Turkey, 35100
      • Ege University Medicine of Faculty-Chest Diseases Department ( Site 2603)
• Ukraine
  • Kyiv, Ukraine, 03057
    • Universal Clinic Oberig-Oncology Center ( Site 2916)
  • Kirovohradska Oblast
    • Kropyvnytskyi, Kirovohradska Oblast, Ukraine, 25011
      • Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 2905)
  • Lvivska Oblast
    • Lviv, Lvivska Oblast, Ukraine, 79059
      • Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital ( Site 2920)
  • Rivnenska Oblast
    • Rivne, Rivnenska Oblast, Ukraine, 33007
      • Rivne Regional Clinical Hospital ( Site 2919)
  • Vinnytska Oblast
    • Vinnytsia, Vinnytska Oblast, Ukraine, 21029
      • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2900)
  • Volynska Oblast
    • Lutsk, Volynska Oblast, Ukraine, 43018
      • Volyn Regional clinical hospital. Regional Medical Oncology Centre. Oncology chemotherapy department ( Site 2918)
• United States
  • California
    • Long Beach, California, United States, 90822
      • VA Long Beach Healthcare System ( Site 2831)
    • Los Angeles, California, United States, 90073
      • VA West Los Angeles Medical Center ( Site 2808)
  • Florida
    • Hollywood, Florida, United States, 33024
      • Millennium Oncology Research Clinic ( Site 2801)
    • Orange City, Florida, United States, 32763
      • Mid Florida Hematology and Oncology Center ( Site 2800)
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center ( Site 2818)
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center ( Site 2828)
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan St. Francis Health ( Site 2812)
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • MFSMC-HJWCI ( Site 2804)
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center ( Site 2829)
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Chan Medical School ( Site 2815)
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Hospital ( Site 2839)
    • Springfield, Missouri, United States, 65807
      • Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 2837)
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey ( Site 2805)
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai ( Site 2821)
    • White Plains, New York, United States, 10601
      • White Plains Hospital ( Site 2835)
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 2816)
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 2827)
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University - Clinical Research Institute ( Site 2813)
  • Texas
    • Houston, Texas, United States, 77090
      • Millennium Research & Clinical Development ( Site 2811)
    • Temple, Texas, United States, 76504
      • Central Texas Veterans health care-Oncology & Hematology ( Site 2819)
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Health System ( Site 2817)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Inclusion Criteria

• Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.
• Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
• Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
• Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain
• Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review
• Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLC
• Has provided tumor tissue sample (tissue biopsy [core, incisional, or excisional])
• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
• Has a life expectancy of at least 6 months

Exclusion Criteria

• Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible
• Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
• Has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention
• Is expected to require any other form of antineoplastic therapy, while on study
• Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Is 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
• 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 medication
• Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has a 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) infection
• Has a known history of Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection
• Has had an allogenic tissue/solid organ transplant

Pemetrexed-specific Criteria:

• Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed
• Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy; For the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to ~14 months). Cycles 1-20 are 21-day cycles. As of protocol amendment 4, participants receiving pembrolizumab/vibostolimab must stop ongoing treatment with pembrolizumab/vibostolimab and will be offered the option to transition to post-cCRT durvalumab consolidation therapy, to complete up to 1 year of consolidation immunotherapy.	Biological: pembrolizumab/vibostolimab; Administered as an intravenous (IV) infusion; Other Names: MK-7684A; Biological: durvalumab; Administered as an IV infusion; Other Names: IMFINZI®; Drug: cisplatin; Cisplatin 75 mg/m^2 administered as an IV infusion in combination with pemetrexed on Day 1 of Cycles 1-3 for non-squamous histology only; In combination with etoposide, cisplatin 50 mg/m^2 is administered on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3; Other Names: PLATINOL-AQ®; Drug: pemetrexed; Pemetrexed 500 mg/m^2 administered as an IV infusion on Day 1 of Cycles 1-3 for non-squamous histology only; Other Names: ALIMTA®; Drug: etoposide; Etoposide 50 mg/m^2 is administered as an IV infusion on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; Other Names: TOPOSAR®; Drug: carboplatin; Carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3, administered as an IV infusion; Other Names: PARAPLATIN®; Drug: paclitaxel; Paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3, administered as an IV infusion; Other Names: TAXOL®; Radiation: thoracic radiotherapy; 60 Gray [Gy] in 2 Gy fractions for 30 days total administered as an external beam radiation
Active Comparator: chemotherapy+radiotherapy+durvalumab; For the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy during Cycles 2 and 3. Following concurrent chemoradiotherapy (cCRT), participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles.	Biological: durvalumab; Administered as an IV infusion; Other Names: IMFINZI®; Drug: cisplatin; Cisplatin 75 mg/m^2 administered as an IV infusion in combination with pemetrexed on Day 1 of Cycles 1-3 for non-squamous histology only; In combination with etoposide, cisplatin 50 mg/m^2 is administered on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3; Other Names: PLATINOL-AQ®; Drug: pemetrexed; Pemetrexed 500 mg/m^2 administered as an IV infusion on Day 1 of Cycles 1-3 for non-squamous histology only; Other Names: ALIMTA®; Drug: etoposide; Etoposide 50 mg/m^2 is administered as an IV infusion on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; Other Names: TOPOSAR®; Drug: carboplatin; Carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3, administered as an IV infusion; Other Names: PARAPLATIN®; Drug: paclitaxel; Paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3, administered as an IV infusion; Other Names: TAXOL®; Radiation: thoracic radiotherapy; 60 Gray [Gy] in 2 Gy fractions for 30 days total administered as an external beam radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience at Least One Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 48 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) For All Participants	ORR is defined as the percentage of participants who have a best response of confirmed 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 Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).	Up to approximately 75 months
Objective Response Rate (ORR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%	ORR is defined as the percentage of participants who have a best response of confirmed 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 Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).	Up to approximately 75 months
Number of Participants Who Experience at Least One Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 75 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 75 months
Duration of Response (DOR) For All Participants	Duration of Response (DOR) is the time from first documented evidence of 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 Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).	Up to approximately 75 months
Duration of Response (DOR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%	Duration of Response (DOR) is the time from first documented evidence of 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 Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).	Up to approximately 75 months
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) For All Participants	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.	Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.	Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning 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, with a higher score indicating a better quality of life.	Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning 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, with a higher score indicating a better quality of life.	Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
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) For All Participants	The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.	Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%	The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.	Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants	The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.	Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%	The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.	Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants	The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.	Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%	The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.	Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For All Participants	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.	Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.	Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.	Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.	Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For All Participants	The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.	Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%	The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.	Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants	The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.	Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%	The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.	Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants	The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.	Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%	The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.	Up to approximately 75 months post randomization

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): August 19, 2026

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Programmed Cell Death-1 (PD1, PD-1); Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase Inhibitors; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Durvalumab; Pemetrexed; Etoposide; Carboplatin; Pembrolizumab; Paclitaxel
• Other Study ID Numbers: 7684A-006; MK-7684A-006 (Other Identifier: MSD); KEYVIBE-006 (Other Identifier: MSD); jRCT2021220015 (Registry Identifier: jRCT); 2021-005135-23 (EudraCT Number); PHRR230831-006071 (Registry Identifier: PHRR); U1111-1285-3656 (Registry Identifier: UTN); 2022-502752-31-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No