RecruitingPhase 3NCT07431827

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

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)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

400 participants

Start Date

Mar 18, 2026

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Calderasib, a biological treatment called MK-3475A, and others for people with non-small cell lung cancer. The study is currently recruiting participants at 65 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCalderasib

MK-1084 oral tablet

BIOLOGICALMK-3475A

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

DRUGPlacebo

Placebo oral tablet

Locations(79)

Instituto Alexander Fleming ( Site 0310)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Sanatorio Parque ( Site 0311)

Rosario, Santa Fe Province, Argentina

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

CABA, Argentina

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

CABA, Argentina

Northern Beaches Hospital ( Site 3009)

Frenchs Forest, New South Wales, Australia

Faculdade de Medicina do ABC ( Site 0415)

Santo André, São Paulo, Brazil

Moncton Hospital ( Site 0200)

Moncton, New Brunswick, Canada

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

Montreal, Quebec, Canada

Peking University People's Hospital ( Site 2100)

Beijing, Beijing Municipality, China

Beijing Cancer hospital ( Site 2106)

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital ( Site 2105)

Beijing, Beijing Municipality, China

Chongqing University Three Gorges Hospital ( Site 2138)

Chongqing, Chongqing Municipality, China

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

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center ( Site 2134)

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital ( Site 2115)

Nanning, Guangxi, China

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

Wuhan, Hubei, China

Xiangya Hospital Central South University ( Site 2136)

Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University ( Site 2121)

Nanchang, Jiangxi, China

Shanghai Pulmonary Hospital ( Site 2125)

Shanghai, Shanghai Municipality, China

Zhongshan Hospital of Fudan University ( Site 2119)

Shanghai, Shanghai Municipality, China

Sichuan Cancer hospital ( Site 2101)

Chengdu, Sichuan, China

The Third Peoples Hospital Of Chengdu ( Site 2141)

Chengdu, Sichuan, China

The Affiliated Cancer Hospital of Xinjiang Medical ( Site 2110)

Urumuqi, Xinjiang, China

Yunnan Province Cancer Hospital ( Site 2131)

Kunming, Yunnan, China

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

Hangzhou, Zhejiang, China

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

Hangzhou, Zhejiang, China

Ningbo No. 2 Hospital ( Site 2124)

Ningbo, Zhejiang, China

Centre de Cancérologie du Grand Montpellier ( Site 1016)

Montpellier, Languedoc-Roussillon, France

Evangelismos General Hospital of Athens ( Site 1204)

Athens, Attica, Greece

Errikos Dunant Hospital Center ( Site 1201)

Athens, Attica, Greece

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

Athens, Attica, Greece

Athens Medical Center ( Site 1202)

Athens, Attica, Greece

Metaxa Cancer Hospital of Piraeus ( Site 1207)

Piraeus, Attica, Greece

G. Papanikolaou General Hospital ( Site 1203)

Thessaloniki, Central Macedonia, Greece

Queen Mary Hospital ( Site 3100)

Hong Kong, Hong Kong

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1400)

Milan, Lombardy, Italy

National Cancer Center ( Site 3603)

Goyang-si, Kyonggi-do, South Korea

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

Suwon, Kyonggi-do, South Korea

Keimyung University Dongsan Hospital ( Site 3605)

Daegu, Taegu-Kwangyokshi, South Korea

Severance Hospital Yonsei University Health System ( Site 3601)

Seoul, South Korea

Asan Medical Center ( Site 3600)

Seoul, South Korea

Hospital Insular de Gran Canaria ( Site 1704)

Las Palmas de Gran Canaria, Canary Islands, Spain

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

Girona, Gerona, Spain

Hospital Puerta de Hierro ( Site 1705)

Majadahonda, Madrid, Spain

Hospital Universitari Vall d'Hebron ( Site 1700)

Barcelona, Spain

Hospital Clinico San Carlos ( Site 1706)

Madrid, Spain

Hospital Universitario la Paz ( Site 1710)

Madrid, Spain

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1707)

Madrid, Spain

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

Málaga, Spain

Hospital Universitario Virgen Macarena ( Site 1709)

Seville, Spain

Taipei Medical University Shuang Ho Hospital ( Site 3700)

New Taipei City, Taiwan

National Cheng Kung University Hospital ( Site 3706)

Tainan, Taiwan

Mackay Memorial Hospital ( Site 3701)

Taipei, Taiwan

Tri-Service General Hospital ( Site 3708)

Taipei, Taiwan

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

Adana, Turkey (Türkiye)

Adana Medical Park Seyhan Hastanesi ( Site 1827)

Adana, Turkey (Türkiye)

Ankara Atatürk Sanatoryum Eğitim ve Araştırma Hastanesi ( Site 1825)

Ankara, Turkey (Türkiye)

Hacettepe Universite Hastaneleri ( Site 1810)

Ankara, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi ( Site 1811)

Ankara, Turkey (Türkiye)

Liv Hospital Ankara ( Site 1828)

Ankara, Turkey (Türkiye)

Kartal Lütfi Kırdar Şehir Hastanesi ( Site 1826)

Istanbul, Turkey (Türkiye)

İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 1815)

Malatya, Turkey (Türkiye)

Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 1824)

Mersin, Turkey (Türkiye)

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

Rize, Turkey (Türkiye)

Sakarya Egitim ve Arastırma Hastanesi ( Site 1817)

Sakarya, Turkey (Türkiye)

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

Cherkasy, Cherkasy Oblast, Ukraine

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

Chernivtsi, Chernivetska Oblast, Ukraine

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

Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine

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

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

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

Kropyvnytskyi, Kirovohrad Oblast, Ukraine

Ukrainian Center of Tomotherapy ( Site 1917)

Kropyvnytskyi, Kirovohrad Oblast, Ukraine

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

Lviv, Lviv Oblast, Ukraine

Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 1902)

Lviv, Lviv Oblast, Ukraine

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

Odesa, Odesa Oblast, Ukraine

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

Rivne, Rivne Oblast, Ukraine

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

Vinnytsia, Vinnytsia Oblast, Ukraine

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

Lutsk, Volyn Oblast, Ukraine

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

Kyiv, Ukraine

Shalimov Institute of Surgery and Transplantation ( Site 1907)

Kyiv, Ukraine

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NCT07431827

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