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A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

Status: Recruiting
Location: See all (122) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.

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

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

• Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c

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

Locations
United States
Alabama
Central Alabama Research ( Site 0108)
RECRUITING
Birmingham
Connecticut
Stamford Hospital ( Site 0126)
RECRUITING
Stamford
Florida
Mount Sinai Cancer Center ( Site 0137)
COMPLETED
Miami Beach
Maine
New England Cancer Specialists ( Site 0139)
RECRUITING
Westbrook
New York
New York Oncology Hematology, P.C. ( Site 0119)
RECRUITING
Albany
Pennsylvania
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)
RECRUITING
Lancaster
Virginia
Blue Ridge Cancer Care ( Site 0144)
RECRUITING
Roanoke
Other Locations
Argentina
Instituto Alexander Fleming ( Site 0311)
RECRUITING
Ciudad Autónoma De Buenos Aires
CEMAIC ( Site 0309)
RECRUITING
Córdoba
Hospital Italiano de Cordoba ( Site 0308)
RECRUITING
Córdoba
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300)
RECRUITING
Mar Del Plata
Australia
The Prince Charles Hospital ( Site 2903)
RECRUITING
Brisbane
Genesis Care- Campbelltown ( Site 2907)
RECRUITING
Campbelltown
Northern Beaches Hospital ( Site 2905)
RECRUITING
Frenchs Forest
Mater Hospital Brisbane ( Site 2906)
RECRUITING
South Brisbane
Austria
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005)
RECRUITING
Graz
Brazil
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0410)
RECRUITING
Florianópolis
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa ( Site 0400)
RECRUITING
Porto Alegre
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto USP ( Site 0419)
RECRUITING
Ribeirão Preto
Faculdade de Medicina do ABC ( Site 0411)
RECRUITING
Santo André
IBCC - Núcleo de Pesquisa e Ensino ( Site 0417)
RECRUITING
São Paulo
Chile
Bradfordhill ( Site 0501)
RECRUITING
Santiago
Centro de Estudios Clínicos SAGA ( Site 0503)
RECRUITING
Santiago
China
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2700)
RECRUITING
Beijing
Sichuan Cancer Hospital. ( Site 2739)
RECRUITING
Chengdu
Chongqing University Cancer Hospital ( Site 2736)
RECRUITING
Chongqing
The First Affiliated Hospital of Fujian Medical University ( Site 2701)
RECRUITING
Fujian
The First Affiliated Hospital of Xiamen University ( Site 2717)
RECRUITING
Fuzhou
AFFILIATED CANCER HOSPITAL AND INSTITUTE OF GUANGZHOU MEDICAL UNIVERSITY ( Site 2743)
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University ( Site 2744)
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital ( Site 2731)
RECRUITING
Hangzhou
Anhui Provincial Cancer Hospital ( Site 2708)
RECRUITING
Hefei
LinYi Cancer Hospital ( Site 2737)
RECRUITING
Linyi
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 2715)
RECRUITING
Nanjing
Affiliated Cancer Hospital of Guangxi Medical University ( Site 2704)
RECRUITING
Nanning
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2724)
RECRUITING
Taizhou
Hubei Cancer Hospital ( Site 2721)
RECRUITING
Wuhan
Tongji Hospital Tongji Medical,Science & Technology ( Site 2722)
RECRUITING
Wuhan
France
Clinique de l'Europe ( Site 1213)
RECRUITING
Amiens
CHU Caen ( Site 1212)
RECRUITING
Caen
Centre Hospitalier Metropole Savoie Site de Chambery ( Site 1208)
RECRUITING
Chambéry
Hopital Europeen Marseille ( Site 1207)
RECRUITING
Marseille
Groupe Hospitalier Paris Saint Joseph ( Site 1215)
RECRUITING
Paris
Hôpital Européen Georges Pompidou ( Site 1214)
RECRUITING
Paris
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1209)
RECRUITING
Vandœuvre-lès-nancy
Greece
Errikos Dunant Hospital Center ( Site 1408)
RECRUITING
Athens
General Hospital of Athens Laiko ( Site 1402)
RECRUITING
Athens
Metropolitan General Hospital ( Site 1400)
RECRUITING
Athens
Agios Andreas Hospital Patras ( Site 1407)
RECRUITING
Pátrai
Papageorgiou General Hospital of Thessaloniki ( Site 1403)
RECRUITING
Thessaloniki
Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 1501)
RECRUITING
Budapest
Reformatus Pulmonologiai Centrum ( Site 1503)
RECRUITING
Törökbálint
Israel
Yitzhak Shamir Medical Center. ( Site 1709)
RECRUITING
Beer Ya Akov
Shaare Zedek Medical Center ( Site 1706)
RECRUITING
Jerusalem
Meir Medical Center. ( Site 1702)
RECRUITING
Kfar Saba
Sheba Medical Center ( Site 1700)
RECRUITING
Ramat Gan
Sourasky Medical Center ( Site 1705)
RECRUITING
Tel Aviv
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1811)
RECRUITING
Bergamo
AOU Renato Dulbecco ( Site 1804)
RECRUITING
Catanzaro
AOU Careggi ( Site 1801)
RECRUITING
Florence
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori ( Site 1807)
RECRUITING
Meldola
A.O.R.N. Antonio Cardarelli ( Site 1810)
RECRUITING
Naples
Policlinico San Matteo ( Site 1802)
RECRUITING
Pavia
Istituto Clinico Humanitas ( Site 1812)
RECRUITING
Rozzano
Ospedale San Giuseppe Moscati ( Site 1816)
RECRUITING
Statte
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 1809)
RECRUITING
Verona
Japan
Nippon Medical School Hospital ( Site 2819)
RECRUITING
Bunkyo
National Hospital Organization Kyushu Medical Center ( Site 2801)
RECRUITING
Fukuoka
National Hospital Organization Himeji Medical Center ( Site 2827)
RECRUITING
Himeji
Hirosaki University Hospital ( Site 2818)
RECRUITING
Hirosaki
Kobe City Medical Center General Hospital ( Site 2811)
RECRUITING
Kobe
Saiseikai Kumamoto Hospital ( Site 2816)
RECRUITING
Kumamoto
Saiseikai Matsusaka Municipal Hospital ( Site 2808)
RECRUITING
Matsusaka
Osaka Metropolitan University Hospital ( Site 2826)
RECRUITING
Osaka
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 2822)
RECRUITING
Sakai
Tohoku University Hospital ( Site 2804)
RECRUITING
Sendai
National Center for Global Health and Medicine ( Site 2806)
RECRUITING
Shinjuku
Tokyo Medical University Hospital ( Site 2829)
RECRUITING
Shinjuku
Takarazuka City Hospital ( Site 2828)
RECRUITING
Takarazuka
Osaka Medical and Pharmaceutical University Hospital ( Site 2810)
RECRUITING
Takatsuki
Fujita Health University Hospital ( Site 2807)
RECRUITING
Toyoake
National Hospital Organization Ureshino Medical Center ( Site 2817)
RECRUITING
Ureshino
Kanagawa Cancer Center ( Site 2820)
RECRUITING
Yokohama
Yokohama Municipal Citizen's Hospital ( Site 2824)
RECRUITING
Yokohama
Malaysia
Hospital Pulau Pinang ( Site 3108)
RECRUITING
George Town
Hospital Wanita and Kanak Kanak Sabah ( Site 3110)
RECRUITING
Kota Kinabalu
Sarawak General Hospital ( Site 3101)
RECRUITING
Kuching
Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2012)
RECRUITING
Gliwice
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 2004)
RECRUITING
Olsztyn
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2008)
RECRUITING
Przemyśl
Republic of Korea
Pusan National University Hospital ( Site 3501)
RECRUITING
Busan
Chungnam National University Hospital ( Site 3503)
RECRUITING
Daejeon
Chonnam National University Hwasun Hospital ( Site 3502)
RECRUITING
Jeollanam-do
Korea University Guro Hospital ( Site 3505)
RECRUITING
Seoul
Kyung Hee University Medical Center ( Site 3500)
RECRUITING
Seoul
Pusan National University Yangsan Hospital ( Site 3504)
RECRUITING
Yangsan
Romania
SC ONCO CARD SRL ( Site 2109)
RECRUITING
Brasov
Delta Health Care SRL ( Site 2108)
RECRUITING
Bucharest
SC MNT Healthcare Europe SRL ( Site 2105)
RECRUITING
Bucharest
Spitalul Clinic Colțea ( Site 2102)
RECRUITING
Bucharest
Institutul Oncologic Prof. Dr. I Chiricuta ( Site 2103)
RECRUITING
Cluj-napoca
Centrul de Oncologie Sfântul Nectarie ( Site 2107)
RECRUITING
Craiova
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2101)
RECRUITING
Florești
Spain
Complejo Hospitalario Universitario A Coruna ( Site 2207)
RECRUITING
A Coruña
Institut Català d'Oncologia (ICO) - Badalona ( Site 2200)
RECRUITING
Badalona
HOSPITAL CLÍNIC DE BARCELONA ( Site 2201)
RECRUITING
Barcelona
Hospital Universitario Ramon y Cajal ( Site 2203)
RECRUITING
Madrid
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 2202)
RECRUITING
Majadahonda
Hospital Universitario Virgen de Valme ( Site 2205)
RECRUITING
Seville
Hospital General Universitario de Valencia ( Site 2204)
RECRUITING
Valencia
Taiwan
Chang Gung Memorial Hospital- Chiayi ( Site 3611)
RECRUITING
Chiayi City
Taipei Medical University Shuang Ho Hospital ( Site 3602)
RECRUITING
New Taipei City
National Cheng Kung University Hospital ( Site 3604)
RECRUITING
Tainan
MacKay Memorial Hospital ( Site 3609)
RECRUITING
Taipei
Tri-Service General Hospital ( Site 3603)
RECRUITING
Taipei
Ukraine
Municipal Enterprise Bukovinian сlinical oncology сenter ( Site 2504)
RECRUITING
Chernivtsi
Shalimov Institute of Surgery and Transplantation Oncology department ( Site 2512)
RECRUITING
Kyiv
Universal Clinic Oberig ( Site 2506)
RECRUITING
Kyiv
Communal noncommercial enterprise of Lviv regional council Lviv oncological regional therapeutical ( Site 2507)
RECRUITING
Lviv
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2517)
RECRUITING
Rivne
United Kingdom
Royal Free Hospital ( Site 2601)
RECRUITING
London
Royal Cornwall Hospital ( Site 2614)
RECRUITING
Truro
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-10-08
Estimated Completion Date: 2032-08-06
Participants
Target number of participants: 675
Treatments
Experimental: Calderasib + Pembrolizumab (+) Berahyaluronidase alfa
Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) plus calderasib until discontinuation criterion is met.
Active_comparator: Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy
Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) and pemetrexed via intravenous (IV) infusion at a dose of 500 mg/m\^2 on days 1 and 22 of cycles 1 and 3 until discontinuation criterion is met PLUS investigator's choice of carboplatin via IV infusion at area under curve (AUC) 5 mg/mL/minute on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks) OR cisplatin via IV infusion at a dose of 75 mg/m\^2 on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks).
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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