A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)

Status: Recruiting
Location: See all (192) locations...
Intervention Type: Biological, Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses: Hypothesis 1: Combination of MK-1084 and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

• Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8

• Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, PD-L1 status, and biomarker research

• If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to \< Grade 1 or baseline

• If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)

• If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load

• If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable

Locations
United States
California
CBCC Global Research, Inc. ( Site 0123)
RECRUITING
Bakersfield
Beverly Hills Cancer Center ( Site 0116)
RECRUITING
Beverly Hills
Florida
Mount Sinai Cancer Center ( Site 0137)
RECRUITING
Miami Beach
Illinois
Orchard Healthcare Research Inc. ( Site 0115)
RECRUITING
Skokie
Missouri
Truman Medical Center ( Site 0126)
RECRUITING
Kansas City
Cox Medical Center North ( Site 0133)
RECRUITING
Springfield
Montana
St. Vincent Frontier Cancer Center-Research ( Site 0105)
RECRUITING
Billings
New Jersey
Atlantic Health System Morristown Medical Center ( Site 0121)
RECRUITING
Morristown
New York
New York Oncology Hematology, P.C. ( Site 0132)
RECRUITING
Albany
Ohio
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103)
RECRUITING
Cincinnati
Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106)
RECRUITING
Kettering
Texas
Oncology Consultants P.A. ( Site 0113)
RECRUITING
Houston
Wisconsin
Circuit Clinical/SSM Health Dean Medical Group ( Site 0129)
RECRUITING
Madison
Other Locations
Argentina
AUSTRAL MEDICAL CENTER ( Site 0302)
COMPLETED
Caba
Centro Oncologico Korben ( Site 0304)
RECRUITING
Caba
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
RECRUITING
Mar Del Plata
Fundacion Estudios Clinicos ( Site 0306)
RECRUITING
Rosario
Sanatorio Parque ( Site 0301)
RECRUITING
Rosario
Australia
Chris O'Brien Lifehouse ( Site 3000)
RECRUITING
Camperdown
Frankston Hospital ( Site 3002)
RECRUITING
Frankston
One Clinical Research ( Site 3001)
RECRUITING
Nedlands
Austria
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 2401)
RECRUITING
Graz
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2400)
RECRUITING
Vienna
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0437)
RECRUITING
Barretos
Hospital Mario Penna ( Site 0436)
RECRUITING
Belo Horizonte
Liga Norte Riograndense Contra o Câncer ( Site 0439)
RECRUITING
Natal
Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro Multidisciplinar de Pesquisa Clínica ( Site 0435)
RECRUITING
Porto Alegre
Hospital de Câncer de Recife ( Site 0447)
RECRUITING
Recife
Americas ( Site 0431)
RECRUITING
Rio De Janeiro
Instituto Nacional de Câncer - INCA ( Site 0446)
RECRUITING
Rio De Janeiro
Oncoclínica Oncologistas Associados ( Site 0441)
RECRUITING
Teresina
Bulgaria
MBAL Uni Hospital-Department of Medical Oncology ( Site 1000)
RECRUITING
Panagyurishte
MHAT - Heart and Brain ( Site 1006)
RECRUITING
Pleven
Multiprofile Hospital for Active Treatment Serdika EOOD-Second Department of Medical Oncology ( Site 1002)
RECRUITING
Sofia
Canada
QEII Health Sciences Centre - Victoria General Site-Dept. of Medical Oncology ( Site 0208)
RECRUITING
Halifax
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0205)
RECRUITING
Hamilton
St. Marys Hospital Center ( Site 0204)
RECRUITING
Montreal
Sunnybrook Research Institute ( Site 0206)
RECRUITING
Toronto
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0207)
RECRUITING
Trois-rivières
CancerCare Manitoba ( Site 0210)
RECRUITING
Winnipeg
Chile
Bradfordhill-Clinical Area ( Site 0504)
RECRUITING
Santiago
Centro de Oncología de Precisión-Oncology ( Site 0502)
RECRUITING
Santiago
FALP-UIDO ( Site 0501)
RECRUITING
Santiago
Orlandi Oncologia-Oncology ( Site 0503)
RECRUITING
Santiago
Clinica Universidad Catolica del Maule-Oncology ( Site 0500)
RECRUITING
Talca
China
Beijing Cancer hospital ( Site 3133)
RECRUITING
Beijing
Beijing Cancer hospital ( Site 3134)
RECRUITING
Beijing
Beijing Chest Hospital,Capital Medical University ( Site 3104)
RECRUITING
Beijing
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3102)
RECRUITING
Beijing
Jilin Province Tumor Hospital ( Site 3107)
RECRUITING
Changchun
Hunan Cancer Hospital ( Site 3141)
RECRUITING
Changsha
The Second Xiangya Hospital of Central South University ( Site 3130)
RECRUITING
Changsha
Sichuan Cancer hospital. ( Site 3109)
RECRUITING
Chengdu
The Third People's Hospital of Chengdu (CDTPH) ( Site 3157)
RECRUITING
Chengdu
West China Hospital, Sichuan University ( Site 3140)
RECRUITING
Chengdu
Army Medical Center of People's Liberation Army ( Site 3142)
RECRUITING
Chongqing
Chongqing University Cancer Hospital ( Site 3119)
RECRUITING
Chongqing
Fujian Cancer Hospital ( Site 3127)
RECRUITING
Fuzhou
Southern Medical University Nanfang Hospital ( Site 3128)
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center ( Site 3137)
RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University ( Site 3108)
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3121)
RECRUITING
Hangzhou
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115)
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital ( Site 3123)
RECRUITING
Harbin
Anhui Provincial Cancer Hospital ( Site 3136)
RECRUITING
Hefei
JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 3124)
RECRUITING
Jiamusi
Shandong Cancer Hospital ( Site 3116)
RECRUITING
Jinan
Yunnan Province Cancer Hospital ( Site 3153)
RECRUITING
Kunming
Taizhou Hospital of Zhejiang Province ( Site 3145)
RECRUITING
Linhai
LinYi Cancer Hospital ( Site 3111)
RECRUITING
Linyi
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3138)
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University ( Site 3139)
RECRUITING
Nanchang
Nanjing First Hospital ( Site 3154)
RECRUITING
Nanjing
Nanjing Gulou Hospital ( Site 3122)
RECRUITING
Nanjing
The Second People's Hospital of Neijiang ( Site 3105)
RECRUITING
Neijiang
Fudan University Shanghai Cancer Center ( Site 3144)
RECRUITING
Shanghai
Shanghai Chest Hospital ( Site 3100)
RECRUITING
Shanghai
Zhongshan Hospital,Fudan University ( Site 3143)
RECRUITING
Shanghai
The First Affiliated Hospital of Soochow University ( Site 3146)
RECRUITING
Suzhou
Shanxi Cancer Hospital ( Site 3131)
RECRUITING
Taiyuan
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 3101)
RECRUITING
Ürümqi
The First Affiliated Hospital of Wenzhou Medical University ( Site 3151)
RECRUITING
Wenzhou
Hubei Cancer Hospital ( Site 3126)
RECRUITING
Wuhan
Tongji Hospital Tongji Medical,Science & Technology ( Site 3113)
RECRUITING
Wuhan
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3155)
RECRUITING
Wuxi
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 3150)
RECRUITING
Xi'an
The First Affiliated hospital of Xiamen University ( Site 3148)
RECRUITING
Xiamen
The Second Affiliated Hospital of Air Force Medical University ( Site 3117)
RECRUITING
Xian
The Second Affiliated Hospital of Air Force Medical University ( Site 3152)
RECRUITING
Xian
Henan Cancer Hospital ( Site 3149)
RECRUITING
Zhengzhou
France
Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1104)
RECRUITING
Avignon
Hôpital Ambroise Paré-Department of Respiratory Diseases and Thoracic Oncology ( Site 1105)
RECRUITING
Boulogne-billancourt
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1101)
RECRUITING
Clermont-ferrand
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1103)
RECRUITING
Dijon
Clinique Teissier Groupe ( Site 1100)
RECRUITING
Valenciennes
Georgia
High Technology Hospital Medcenter ( Site 1203)
RECRUITING
Batumi
American Hospital Network LLC ( Site 1208)
RECRUITING
Tbilisi
Cancer Research Centre. Mardaleishvili Medical Centre ( Site 1205)
RECRUITING
Tbilisi
Caucasus Medical Centre ( Site 1202)
RECRUITING
Tbilisi
New Hospitals ( Site 1200)
RECRUITING
Tbilisi
Tbilisi Institute of Medicine ( Site 1206)
RECRUITING
Tbilisi
Todua Clinic, LLC ( Site 1204)
RECRUITING
Tbilisi
TSMU and Ingorokva High Medical Technology University Clinic LTD ( Site 1201)
RECRUITING
Tbilisi
Germany
Krankenhaus Bethanien ( Site 1303)
RECRUITING
Solingen
Marienhospital Stuttgart ( Site 1302)
RECRUITING
Stuttgart
Greece
THORACIC GENERAL HOSPITAL OF ATHENS I SOTIRIA-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1400)
RECRUITING
Athens
University General Hospital of Larissa-Oncology Clinic ( Site 1403)
RECRUITING
Larissa
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1402)
RECRUITING
Pátrai
Agios Loukas Clinic ( Site 1404)
RECRUITING
Thessaloniki
G. Papanikolaou General Hospital-Pulmonary Clinic of Aristotle University of Thessaloniki ( Site 1405)
RECRUITING
Thessaloniki
Italy
CRO-IRCCS-Clinical Oncology ( Site 1605)
RECRUITING
Aviano
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno-UOC Oncologia Medica Livorno ( Site 1608)
RECRUITING
Livorno
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1600)
RECRUITING
Milan
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1604)
RECRUITING
Milan
A.O.R.N. Ospedale dei Colli - Monaldi V.-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1602)
RECRUITING
Naples
Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia clinica sperimentale Toraco-Polmonare ( Site 1607)
RECRUITING
Napoli
Istituto Oncologico Veneto IRCCS-Oncologia 2 ( Site 1603)
RECRUITING
Padua
Ospedale Santa Maria delle Croci ( Site 1606)
RECRUITING
Ravenna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1601)
RECRUITING
Rome
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1609)
RECRUITING
Rome
Japan
Nippon Medical School Hospital ( Site 3306)
RECRUITING
Bunkyo
Chiba University Hospital ( Site 3322)
RECRUITING
Chiba
National Hospital Organization Kyushu Cancer Center ( Site 3316)
RECRUITING
Fukuoka
Kansai Medical University Hospital ( Site 3312)
RECRUITING
Hirakata
Hiroshima City Hiroshima Citizens Hospital ( Site 3314)
RECRUITING
Hiroshima
Kanazawa University Hospital ( Site 3308)
RECRUITING
Kanazawa
St. Marianna University Hospital ( Site 3320)
RECRUITING
Kawasaki
Saitama Prefectural Cancer Center ( Site 3304)
RECRUITING
Kitaadachi-gun
Saiseikai Kumamoto Hospital ( Site 3318)
RECRUITING
Kumamoto
Kurume University Hospital ( Site 3317)
RECRUITING
Kurume
Matsusaka Municipal Hospital ( Site 3311)
RECRUITING
Matsusaka
National Hospital Organization Shikoku Cancer Center ( Site 3315)
RECRUITING
Matsuyam
Nagoya University Hospital ( Site 3309)
RECRUITING
Nagoya
Miyagi Cancer Center ( Site 3301)
RECRUITING
Natori-shi
Osaka Metropolitan University Hospital ( Site 3321)
RECRUITING
Osaka
Gunma Prefectural Cancer Center ( Site 3302)
RECRUITING
Ōta
Toho University Omori Medical Center ( Site 3319)
RECRUITING
Ōta-ku
Sendai Kousei Hospital ( Site 3300)
RECRUITING
Sendai
National Center for Global Health and Medicine ( Site 3305)
RECRUITING
Shinjuku
Tokyo Medical University Hospital ( Site 3307)
RECRUITING
Shinjuku
Osaka Medical and Pharmaceutical University Hospital ( Site 3313)
RECRUITING
Takatsuki
Fujita Health University Hospital ( Site 3310)
RECRUITING
Toyoake
Mexico
Arké SMO S.A. de C.V. ( Site 0602)
RECRUITING
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez-Hematologia and Oncologia ( Site 0600)
RECRUITING
Monterrey
Oaxaca Site Management Organization S.C. ( Site 0603)
RECRUITING
Oaxaca City
Netherlands
Ziekenhuis St. Jansdal-Poli Longziekten ( Site 1701)
RECRUITING
Harderwijk
Universitair Medisch Centrum Utrecht ( Site 1704)
RECRUITING
Utrecht
Isala, locatie Zwolle-Poli Longziekten ( Site 1700)
RECRUITING
Zwolle
New Zealand
Auckland City Hospital ( Site 3400)
RECRUITING
Auckland
Philippines
Lung Center of the Philippines-Pulmonary, Critical Care and Sleep Medicine ( Site 3503)
RECRUITING
Quezon City
Veterans Memorial Medical Center-Section of Oncology ( Site 3505)
RECRUITING
Quezon City
Poland
Szpital Specjalistyczny im. Henryka Klimontowicza ( Site 1801)
RECRUITING
Gorlice
Pratia MCM Krakow ( Site 1808)
RECRUITING
Krakow
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1804)
RECRUITING
Przemyśl
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1800)
RECRUITING
Warsaw
Republic of Korea
The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3606)
RECRUITING
Bupyeong-gu
Chonnam National University Hwasun Hospital-Pulmonology ( Site 3604)
RECRUITING
Hwasun
Chungnam national university hospital ( Site 3602)
RECRUITING
Junggu
Korea University Guro Hospital ( Site 3601)
RECRUITING
Seoul
Kyung Hee University Hospital ( Site 3605)
RECRUITING
Seoul
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3600)
RECRUITING
Suwon
Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3603)
RECRUITING
Yangsan
Romania
SC ONCO CARD SRL ( Site 1995)
RECRUITING
Brasov
Institutul Oncologic Cluj-Oncologie Medicala ( Site 1999)
RECRUITING
Cluj-napoca
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1994)
RECRUITING
Craiova
Sigmedical Services SRL ( Site 1997)
RECRUITING
Suceava
Cabinet Medical Oncomed ( Site 1998)
RECRUITING
Timișoara
Spain
Hospital Universitari Vall d Hebron ( Site 2010)
RECRUITING
Barcelona
Hospital Insular de Gran Canaria-Oncology ( Site 2019)
RECRUITING
Las Palmas De Gran Canaria
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2012)
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 2017)
RECRUITING
Madrid
H.R.U Málaga - Hospital General-Oncology ( Site 2014)
RECRUITING
Málaga
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2015)
RECRUITING
Seville
Turkey
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2107)
RECRUITING
Adana
Ankara Bilkent Şehir Hastanesi ( Site 2100)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2101)
RECRUITING
Ankara
Memorial Ankara Hastanesi-Medical Oncology ( Site 2106)
RECRUITING
Ankara
SBU GULHANE EGITIM VE ARASTIRMA HASTANESI Onkoloji ( Site 2104)
RECRUITING
Ankara
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2102)
RECRUITING
Bornova
Medipol Mega Universite Hastanesi-oncology ( Site 2105)
RECRUITING
Istanbul
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2103)
RECRUITING
Istanbul
Ukraine
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 2209)
RECRUITING
Cherkasy
Regional Municipal Non-profit Enterprise Bukovinian Clinica-structural unit of the clinical trials ( Site 2210)
RECRUITING
Chernivtsi
Communal Non-Commercial Enterprise Prykarpatski Clinical On-Surgery department #2 ( Site 2202)
RECRUITING
Ivano-frankivsk
Medical Center MedOffice Group ( Site 2219)
RECRUITING
Kiev
Kirovohrad Regional Oncology Center-Chemotherapy department ( Site 2204)
RECRUITING
Kropyvnytskyi
Medical Center Mriya Med-Service-Clinical Research Department ( Site 2215)
RECRUITING
Kryvyi Rih
ME Volyn Regional Clinical Hospital of the Volyn Regional Council ( Site 2216)
RECRUITING
Lutsk
Municipal non-profit enterprise Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2217)
RECRUITING
Lviv
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2920)
RECRUITING
Rivne
Rivne Regional Clinical Hospital ( Site 2205)
COMPLETED
Rivne
Communal Noncommercial Enterprise Podillia Regional Oncolog-Cardiothoracic department ( Site 2211)
RECRUITING
Vinnytsia
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-05-24
Estimated Completion Date: 2031-02-18
Participants
Target number of participants: 600
Treatments
Experimental: MK-1084 with Pembrolizumab
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and MK-1084 by oral tablets until discontinuation criterion is met.
Active_comparator: Placebo with Pembrolizumab
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and placebo by oral tablets once daily until discontinuation criterion is met.
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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