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RECRUITING

NCT07431827

PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-03-18

Completion Date

2039-10-26

Last Updated

2026-07-10

Healthy Volunteers

Conditions

Non-small Cell Lung Cancer

Interventions

DRUG

Calderasib

MK-1084 oral tablet

BIOLOGICAL

MK-3475A

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

DRUG

Placebo

Placebo oral tablet

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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

Locations (65)

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

Moncton Hospital ( Site 0200)

Moncton, New Brunswick, Canada

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

Sichuan Cancer hospital ( Site 2101)

Chengdu, Sichuan, China

The Third Peoples Hospital Of Chengdu ( Site 2141)

Chengdu, Sichuan, China

Yunnan Province Cancer Hospital ( Site 2131)

Kunming, Yunnan, 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

Queen Mary Hospital ( Site 3100)

Hong Kong, Hong Kong

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)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (65)