AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3KANDLELIT-013NCT07431827

MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)

A Phase 3 study testing Calderasib and MK-3475A in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 115 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Calderasib and MK-3475A
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
115 sitesin 18 countries
Study dates
18 Mar 2026to 26 Oct 2039
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a histological/cytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria:
  • Has newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC
  • Has completely resected, pathological Stage IIA-IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy.
  • Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
  • No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention.
  • Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest/abdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization
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  • Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention
  • Human immunodeficiency virus-infected participants must have well controlled HIV on antiretroviral therapy
  • Participants who are Hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Who cannot join

  • Has a diagnosis of any 1 of the following tumor types/locations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention
  • Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, or malabsorption)
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
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  • Has an active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has active infection requiring systemic therapy
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Trial locations and contacts

115 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

115 sites in 18 countries

China27 sites, 27 recruiting

  • Peking University People's Hospital ( Site 2100)

    Beijing, Beijing Municipality, 100044

    Study Coordinator, 010-88326666

    Recruiting

  • Beijing Cancer hospital ( Site 2106)

    Beijing, Beijing Municipality, 100142

    Study Coordinator, 010-88121122

    Recruiting

  • Peking Union Medical College Hospital ( Site 2105)

    Beijing, Beijing Municipality, 100730

    Study Coordinator, 010-69154116

    Recruiting

  • Xiangya Hospital Central South University ( Site 2136)

    Changsha, Hunan, 410008

    Study Coordinator, +8673184327918

    Recruiting

  • Hunan Cancer Hospital ( Site 2112)

    Changsha, Hunan, 410013

    Study Coordinator, +86073189762210

    Recruiting

  • West China Hospital, Sichuan University ( Site 2142)

    Chengdu, Sichuan, 610000

    Study Coordinator, +8602885422114

    Recruiting

  • The Third Peoples Hospital Of Chengdu ( Site 2141)

    Chengdu, Sichuan, 610014

    Study Coordinator, +8602861318720

    Recruiting

  • Sichuan Cancer hospital ( Site 2101)

    Chengdu, Sichuan, 610041

    Study Coordinator, +8663066886

    Recruiting

  • Chongqing University Three Gorges Hospital ( Site 2138)

    Chongqing, Chongqing Municipality, 404199

    Study Coordinator, +8613896327099

    Recruiting

  • The First Affiliated Hospital Of Fujian Medical University ( Site 2123)

    Fuzhou, Fujian, 350005

    Study Coordinator, +8659187982222

    Recruiting

  • Fujian Cancer Hospital ( Site 2122)

    Fuzhou, Fujian, 350014

    Study Coordinator, 0591-83660063

    Recruiting

  • Sun Yat-sen University Cancer Center ( Site 2134)

    Guangzhou, Guangdong, 510060

    Study Coordinator, +8613560405144

    Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 2118)

    Hangzhou, Zhejiang, 310009

    Study Coordinator, 0571-86090073

    Recruiting

  • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 2103)

    Hangzhou, Zhejiang, 310009

    Study Coordinator, +86057187236114

    Recruiting

  • Zhejiang Cancer Hospital ( Site 2117)

    Hangzhou, Zhejiang, 310022

    Study Coordinator, 0571-88122222

    Recruiting

  • Fourth Hospital Of Hebei Medical University ( Site 2107)

    Hshijiazhuang, Hebei, 050010

    Study Coordinator, +86 0311 - 86095588

    Recruiting

  • Affiliated Cancer Hospital of Shandong First Medical University ( Site 2111)

    Jinan, Shandong, 250117

    Study Coordinator, 0531-87984777

    Recruiting

  • Yunnan Province Cancer Hospital ( Site 2131)

    Kunming, Yunnan, 650118

    Study Coordinator, +867168178106

    Recruiting

  • The First Affiliated Hospital of Nanchang University ( Site 2121)

    Nanchang, Jiangxi, 330000

    Study Coordinator, +86079188695051

    Recruiting

  • Guangxi Medical University Cancer Hospital ( Site 2115)

    Nanning, Guangxi, 530200

    Study Coordinator, 0771-5310848

    Recruiting

  • Ningbo No. 2 Hospital ( Site 2124)

    Ningbo, Zhejiang, 315010

    Study Coordinator, 0574-83870375

    Recruiting

  • Shanghai Pulmonary Hospital ( Site 2125)

    Shanghai, Shanghai Municipality, 200000

    Study Coordinator, 021-65115006-1027

    Recruiting

  • Fudan University Shanghai Cancer Center ( Site 2137)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, 021-64175590

    Recruiting

  • Zhongshan Hospital of Fudan University ( Site 2119)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, 021131587861

    Recruiting

  • The Affiliated Cancer Hospital of Xinjiang Medical ( Site 2110)

    Urumuqi, Xinjiang, 830054

    Study Coordinator, +8613899913829

    Recruiting

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 2140)

    Wuhan, Hubei, 430000

    Study Coordinator, +8618872257224

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 2139)

    Wuhan, Hubei, 430048

    Study Coordinator, +862783261400

    Recruiting

Other trials in China

Ukraine15 sites, 15 recruiting

  • COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 1904)

    Cherkasy, Cherkasy Oblast, 18009

    Study Coordinator, +380472370123

    Recruiting

  • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 1909)

    Chernivtsi, Chernivetska Oblast, 58013

    Study Coordinator, +380505144910

    Recruiting

  • Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio ( Site 1900)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

    Study Coordinator, +380342507353

    Recruiting

  • Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 1916)

    Kropyvnytskyi, Kirovohrad Oblast, 25006

    Study Coordinator, +380969680396

    Recruiting

  • Ukrainian Center of Tomotherapy ( Site 1917)

    Kropyvnytskyi, Kirovohrad Oblast, 25011

    Study Coordinator, +380958718674

    Recruiting

  • Medical Center "Mriya Med-Service" ( Site 1911)

    Kryvyi Rih, Dnipropetrovsk Oblast, 50000

    Study Coordinator, +380677490687

    Recruiting

  • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1915)

    Kyiv, 03057

    Study Coordinator, +380669472333

    Recruiting

  • Kyiv City Clinical Oncology Center ( Site 1918)

    Kyiv, 03115

    Study Coordinator, +380503818536

    Recruiting

  • Shalimov Institute of Surgery and Transplantation ( Site 1907)

    Kyiv, 03126

    Study Coordinator, +380444081800

    Recruiting

  • Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council ( Site 1914)

    Lutsk, Volyn Oblast, 43018

    Study Coordinator, +380332773100

    Recruiting

  • Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 1908)

    Lviv, Lviv Oblast, 79031

    Study Coordinator, +380973342609

    Recruiting

  • Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 1902)

    Lviv, Lviv Oblast, 79059

    Study Coordinator, +380977453295

    Recruiting

  • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 1913)

    Odesa, Odesa Oblast, 65025

    Study Coordinator, +380931860876

    Recruiting

  • ME "Rivne Regional Antitumor Center" Rivne Regional Council ( Site 1912)

    Rivne, Rivne Oblast, 33010

    Study Coordinator, +380971921000

    Recruiting

  • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 1903)

    Vinnytsia, Vinnytsia Oblast, 21029

    Study Coordinator, +380988936318

    Recruiting

Other trials in Ukraine

Turkey (Türkiye)11 sites, 11 recruiting

  • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1812)

    Adana, 01250

    Study Coordinator, +905318328585

    Recruiting

  • Adana Medical Park Seyhan Hastanesi ( Site 1827)

    Adana, 1140

    Study Coordinator, +90 539 607 7471

    Recruiting

  • Ankara Atatürk Sanatoryum Eğitim ve Araştırma Hastanesi ( Site 1825)

    Ankara, 06280

    Study Coordinator, +9005360653456

    Recruiting

  • Hacettepe Universite Hastaneleri ( Site 1810)

    Ankara, 06410

    Study Coordinator, +90 5415762496

    Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 1811)

    Ankara, 06800

    Study Coordinator, +905546820294

    Recruiting

  • Liv Hospital Ankara ( Site 1828)

    Ankara, 6680

    Study Coordinator, +90 5520045315

    Recruiting

  • Kartal Lütfi Kırdar Şehir Hastanesi ( Site 1826)

    Istanbul, 34865

    Study Coordinator, +90 536 719 73 95

    Recruiting

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 1815)

    Malatya, 44280

    Study Coordinator, +905396194044

    Recruiting

  • Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 1824)

    Mersin, 33240

    Study Coordinator, +905074436940

    Recruiting

  • Recep Tayyip Erdogan University Training and Research Hospital ( Site 1816)

    Rize, 53020

    Study Coordinator, +905546815042

    Recruiting

  • Sakarya Egitim ve Arastırma Hastanesi ( Site 1817)

    Sakarya, 54100

    Study Coordinator, +905546557924

    Recruiting

Other trials in Turkey (Türkiye)

Spain9 sites, 9 recruiting

  • Hospital Universitari Vall d'Hebron ( Site 1700)

    Barcelona, 08035

    Study Coordinator, +34932746000

    Recruiting

  • Institut Català d'Oncologia (ICO) - Girona ( Site 1703)

    Girona, Gerona, 17007

    Study Coordinator, +34972225834

    Recruiting

  • Hospital Insular de Gran Canaria ( Site 1704)

    Las Palmas de Gran Canaria, Canary Islands, 35016

    Study Coordinator, 34 928441738

    Recruiting

  • Hospital Clinico San Carlos ( Site 1706)

    Madrid, 28040

    Study Coordinator, 91 330 30 00

    Recruiting

  • Hospital Universitario la Paz ( Site 1710)

    Madrid, 28046

    Study Coordinator, +34917277516

    Recruiting

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1707)

    Madrid, 28223

    Study Coordinator, 913303000

    Recruiting

  • Hospital Puerta de Hierro ( Site 1705)

    Majadahonda, Madrid, 28222

    Study Coordinator, +34911917759

    Recruiting

  • H.R.U Malaga - Hospital General ( Site 1708)

    Málaga, 29010

    Study Coordinator, 951290000

    Recruiting

  • Hospital Universitario Virgen Macarena ( Site 1709)

    Seville, 41009

    Study Coordinator, +34955008000

    Recruiting

Other trials in Spain

Brazil7 sites, 7 recruiting

  • Hospital Madre Teresa ( Site 0420)

    Belo Horizonte, Minas Gerais, 30441-070

    Study Coordinator, +553133398115

    Recruiting

  • PRONUTRIR ( Site 0425)

    Fortaleza, Ceará, 60810-180

    Study Coordinator, +55 (85) 3048-0533

    Recruiting

  • Real Hospital Portugues ( Site 0418)

    Recife, Pernambuco, 52010-075

    Study Coordinator, +5581996214574

    Recruiting

  • Faculdade de Medicina do ABC ( Site 0415)

    Santo André, São Paulo, 09060-870

    Study Coordinator, +551149935491

    Recruiting

  • Hospital Alemao Oswaldo Cruz ( Site 0416)

    São Paulo, 01327-001

    Study Coordinator, +551135491542

    Recruiting

  • Instituto do Câncer Brasil - Unidade Taubaté ( Site 0424)

    Taubaté, São Paulo, 12030-200

    Study Coordinator, +5512996706805

    Recruiting

  • AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0414)

    Vitória, Espírito Santo, 29043-260

    Study Coordinator, +5527998469004

    Recruiting

Other trials in Brazil

Greece6 sites, 6 recruiting

  • Evangelismos General Hospital of Athens ( Site 1204)

    Athens, Attica, 106 76

    Study Coordinator, +30 21 3204 1000

    Recruiting

  • Errikos Dunant Hospital Center ( Site 1201)

    Athens, Attica, 115 26

    Study Coordinator, +302107470960

    Recruiting

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1206)

    Athens, Attica, 115 27

    Study Coordinator, +302107700220

    Recruiting

  • Athens Medical Center ( Site 1202)

    Athens, Attica, 151 25

    Study Coordinator, +302107464642

    Recruiting

  • Metaxa Cancer Hospital of Piraeus ( Site 1207)

    Piraeus, Attica, 185 37

    Study Coordinator, +306940583449

    Recruiting

  • G. Papanikolaou General Hospital ( Site 1203)

    Thessaloniki, Central Macedonia, 570 10

    Study Coordinator, 0030 231330787476

    Recruiting

Other trials in Greece

Colombia5 sites, 5 recruiting

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0601)

    Bogota, Cundinamarca, 110131

    Study Coordinator, 573016348173

    Recruiting

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0603)

    Bogotá, Bogota D.C., 111321

    Study Coordinator, +573203247267

    Recruiting

  • Promotora Médica Las Américas S.A. ( Site 0602)

    Medellín, Antioquia, 050034

    Study Coordinator, +5734093935461

    Recruiting

  • Instituto Médico de Alta Tecnología S.A.S. ( Site 0605)

    Montería, Departamento de Córdoba, 230002

    Study Coordinator, +573158441430

    Recruiting

  • Oncologos Del Occidente ( Site 0606)

    Pereira, Risaralda Department, 661001

    Study Coordinator, +573123887343

    Recruiting

Other trials in Colombia

South Korea5 sites, 5 recruiting

  • Keimyung University Dongsan Hospital ( Site 3605)

    Daegu, Taegu-Kwangyokshi, 42601

    Study Coordinator, 82-53-258-6671

    Recruiting

  • National Cancer Center ( Site 3603)

    Goyang-si, Kyonggi-do, 10408

    Study Coordinator, 82-31-920-1676

    Recruiting

  • Severance Hospital Yonsei University Health System ( Site 3601)

    Seoul, 03722

    Study Coordinator, +8215991004

    Recruiting

  • Asan Medical Center ( Site 3600)

    Seoul, 05505

    Study Coordinator, +82-2-3010-3214

    Recruiting

  • The Catholic University of Korea St. Vincent s Hospital ( Site 3602)

    Suwon, Kyonggi-do, 16247

    Study Coordinator, +82 31 249 8485

    Recruiting

Other trials in South Korea

Taiwan5 sites, 5 recruiting

  • Taipei Medical University Shuang Ho Hospital ( Site 3700)

    New Taipei City, 235

    Study Coordinator, +886-970-747-515

    Recruiting

  • National Cheng Kung University Hospital ( Site 3706)

    Tainan, 704

    Study Coordinator, +886-6-2353535#3120

    Recruiting

  • Mackay Memorial Hospital ( Site 3701)

    Taipei, 10449

    Study Coordinator, +886-2543-3535

    Recruiting

  • National Taiwan University Cancer Center (NTUCC) ( Site 3707)

    Taipei, 106

    Study Coordinator, +886-2-2312-3456

    Recruiting

  • Tri-Service General Hospital ( Site 3708)

    Taipei, 11490

    Study Coordinator, 886-2-87923311#13899

    Recruiting

Other trials in Taiwan

Argentina4 sites, 4 recruiting

  • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0306)

    CABA, C1199ABB

    Study Coordinator, +541149590200

    Recruiting

  • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0309)

    CABA, C1431FWO

    Study Coordinator, +5491160006609

    Recruiting

  • Instituto Alexander Fleming ( Site 0310)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

    Study Coordinator, +541132218900

    Recruiting

  • Sanatorio Parque ( Site 0311)

    Rosario, Santa Fe Province, S2000DSV

    Study Coordinator, +5493416955611

    Recruiting

Other trials in Argentina

Chile4 sites, 4 recruiting

  • Clínica MEDS La Dehesa ( Site 0509)

    Lo Barnechea, Region M. de Santiago, 7691236

    Study Coordinator, +5622499 6400

    Recruiting

  • Fundación Arturo López Pérez ( Site 0501)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56224205098

    Recruiting

  • Centro de Oncología de Precisión ( Site 0503)

    Santiago, Region M. de Santiago, 7560908

    Study Coordinator, +56953796258

    Recruiting

  • Bradford Hill ( Site 0508)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56229490970

    Recruiting

Other trials in Chile

Australia3 sites, 3 recruiting

  • Peninsula University Hospital ( Site 3011)

    Frankston, Victoria, 3199

    Study Coordinator, +61397847777

    Recruiting

  • Northern Beaches Hospital ( Site 3009)

    Frenchs Forest, New South Wales, 2086

    Study Coordinator, +6191055083

    Recruiting

  • Princess Alexandra Hospital ( Site 3012)

    Woolloongabba, Queensland, 4102

    Study Coordinator, +61731762111

    Recruiting

Other trials in Australia

Canada3 sites, 3 recruiting

  • CIUSSS- saguenay-Lac-Saint-Jean ( Site 0216)

    Chicoutimi, Quebec, G7H 5H6

    Study Coordinator, 418 541-1000

    Recruiting

  • Moncton Hospital ( Site 0200)

    Moncton, New Brunswick, E1C 6Z8

    Study Coordinator, 5068575104

    Recruiting

  • Centre Hospitalier de l'Université de Montréal ( Site 0219)

    Montreal, Quebec, H2X 3E4

    Study Coordinator, 5148908000x26832

    Recruiting

Other trials in Canada

Italy3 sites, 3 recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1400)

    Milan, Lombardy, 20133

    Study Coordinator, +390223903816

    Recruiting

  • IEO Istituto Europeo di Oncologia ( Site 1405)

    Milan, Lombardy, 20141

    Study Coordinator, +390257489482

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401)

    Roma, 00168

    Study Coordinator, 0630156050

    Recruiting

Other trials in Italy

France2 sites, 2 recruiting

  • Centre Hospitalier Intercommunal ( Site 1019)

    Créteil, Val-de-Marne, 94010

    Study Coordinator, +33157022101

    Recruiting

  • Centre de Cancérologie du Grand Montpellier ( Site 1016)

    Montpellier, Languedoc-Roussillon, 34070

    Study Coordinator, +33 4 30 29 73 96

    Recruiting

Other trials in France

Hong Kong2 sites, 2 recruiting

  • Queen Mary Hospital ( Site 3100)

    Hong Kong

    Study Coordinator, 85239103299

    Recruiting

  • Tuen Mun Hospital ( Site 3102)

    Hong Kong

    Study Coordinator, +85224685111

    Recruiting

Other trials in Hong Kong

Japan2 sites, 2 recruiting

  • Fukushima Medical University Hospital ( Site 2202)

    Fukushima, 960-1295

    Study Coordinator, +81-24-547-1111

    Recruiting

  • Hospital of the University of Occupational and Environmental Health, Japan ( Site 2214)

    Kitakyushu, Fukuoka, 807-8556

    Study Coordinator, +81-93-603-1611

    Recruiting

Other trials in Japan

United Kingdom2 sites, 2 recruiting

  • Imperial College Healthcare NHS Trust, Charing Cross Hospital ( Site 2012)

    London, London, City of, W6 8RF

    Study Coordinator, +4402033111234

    Recruiting

  • Queen Alexandra Hospital ( Site 2011)

    Portsmouth, PO6 3LY

    Study Coordinator, +4402392286000

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)

This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.

Being tested
Calderasib, MK-3475A, Placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CalderasibDrug

    Also called MK-1084

    MK-1084 oral tablet

  • MK-3475ABiological

    Also called Pembrolizumab (+) Berahyaluronidase alfa

    Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.

  • PlaceboDrug

    Placebo oral tablet

Study groups in NCT07431827
Study groupRoleWhat they receive
Calderasib + MK-3475AExperimentalParticipants receive calderasib daily (qd) and MK-3475A every 6 weeks (q6w) for up to 9 doses.
Receives: Drug: Calderasib; Biological: MK-3475A
Placebo + MK-3475AActive comparatorParticipants receive placebo qd and MK-3475A q6w for up to 9 doses.
Receives: Biological: MK-3475A; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival (DFS)

    DFS is the time from randomization to any recurrence (local, locoregional, regional, or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.

    Measured: Up to ~11 years

Secondary outcomes (11)

  1. Overall Survival (OS)

    OS is the time from randomization to death due to any cause.

    Measured: Up to ~11 years

  2. Distant Metastasis-Free Survival (DMFS)

    DMFS is the time from randomization to the first documented distant metastasis or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.

    Measured: Up to ~11 years

  3. Lung Cancer Specific Survival (LCSS)

    LCSS is the time from randomization to the date of death due to lung cancer.

    Measured: Up to ~11 years

  4. Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

    Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30).

    Measured: Up to ~11 years

  5. Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score

    Change from baseline in physical functioning score (QLQ-C30 Items 1 to 5).

    Measured: Up to ~11 years

  6. Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score

    Change from baseline in role functioning score (QLQ-C30 Items 6 and 7).

    Measured: Up to ~11 years

  7. Change from Baseline in the EORTC-QLQ-C30 Dyspnea (Item 8) Score

    Change from baseline in dyspnea (QLQ-C30 Item 8).

    Measured: Up to ~11 years

  8. Change from Baseline in the EORTC-Quality of Life Questionnaire-Lung Cancer 24 (QLQ-LC24) Coughing (Items 31 and 52) Combined Score

    Change from baseline in coughing scores (EORTC QLQ-LC24 Items 31 and 52).

    Measured: Up to ~11 years

  9. Change from Baseline in the EORTC-QLQ-LC24 Chest Pain (Item 40) Score

    Change from baseline in chest pain score (EORTC QLQ-LC24 Item 40).

    Measured: Up to ~11 years

  10. Number of Participants Who Experience an Adverse Event (AE)

    Number of participants with ≥1 AE.

    Measured: Up to ~13.5 years

  11. Number of Participants Who Discontinue Study Treatment Due to an AE

    Number of participants discontinuing from study therapy due to AE.

    Measured: Up to ~13.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2026
  2. Study start18 Mar 2026
  3. Primary completion26 Oct 2039 (estimated)
  4. Study completion26 Oct 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07431827
Sponsor's protocol ID
1084-013
Other IDs
U1111-1312-0627, 2024-517337-41-00, jRCT2071260063
Acronym
KANDLELIT-013
Status last verified
Oct 2026
First submitted
19 Feb 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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