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

NCT07431827 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 1084-013U1111-1312-06272024-517337-41-00
• Study Type: interventional
• Target: 400
• Locations: 13 countries
• Sites: 72

Brief 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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (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.

  Up to ~11 years

Secondary Outcomes (11)

• Overall Survival (OS)

  Up to ~11 years

• Distant Metastasis-Free Survival (DMFS)

  Up to ~11 years

• Lung Cancer Specific Survival (LCSS)

  Up to ~11 years

• 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

  Up to ~11 years

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

  Up to ~11 years

Study Arms (2)

Calderasib + MK-3475A

EXPERIMENTAL

Participants receive calderasib daily (qd) and MK-3475A every 6 weeks (q6w) for up to 9 doses.

Drug: Calderasib; Biological: MK-3475A

Placebo + MK-3475A

ACTIVE COMPARATOR

Participants receive placebo qd and MK-3475A q6w for up to 9 doses.

Biological: MK-3475A; Drug: Placebo

Interventions

Placebo DRUG

Placebo oral tablet

Placebo + MK-3475A

MK-3475A BIOLOGICAL

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

Also known as: Pembrolizumab (+) Berahyaluronidase alfa

Calderasib + MK-3475A; Placebo + MK-3475A

Calderasib DRUG

MK-1084 oral tablet

Also known as: MK-1084

Calderasib + MK-3475A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (72)

Instituto Alexander Fleming ( Site 0310)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

RECRUITING

Sanatorio Parque ( Site 0311)

Rosario, Santa Fe Province, S2000DSV, Argentina

RECRUITING

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

CABA, C1199ABB, Argentina

RECRUITING

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

CABA, C1431FWO, Argentina

RECRUITING

Northern Beaches Hospital ( Site 3009)

Frenchs Forest, New South Wales, 2086, Australia

RECRUITING

Moncton Hospital ( Site 0200)

Moncton, New Brunswick, E1C 6Z8, Canada

RECRUITING

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

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Peking Union Medical College Hospital ( Site 2105)

Beijing, Beijing Municipality, 100730, China

RECRUITING

Chongqing University Three Gorges Hospital ( Site 2138)

Chongqing, Chongqing Municipality, 404199, China

RECRUITING

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

Fuzhou, Fujian, 350005, China

RECRUITING

Sun Yat-sen University Cancer Center ( Site 2134)

Guangzhou, Guangdong, 510060, China

RECRUITING

Guangxi Medical University Cancer Hospital ( Site 2115)

Nanning, Guangxi, 530200, China

RECRUITING

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

Wuhan, Hubei, 430048, China

RECRUITING

Xiangya Hospital Central South University ( Site 2136)

Changsha, Hunan, 410008, China

RECRUITING

Shanghai Pulmonary Hospital ( Site 2125)

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Sichuan Cancer hospital ( Site 2101)

Chengdu, Sichuan, 610000, China

RECRUITING

The Third Peoples Hospital Of Chengdu ( Site 2141)

Chengdu, Sichuan, 610031, China

RECRUITING

Yunnan Province Cancer Hospital ( Site 2131)

Kunming, Yunnan, 650118, China

RECRUITING

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

Hangzhou, Zhejiang, 310009, China

RECRUITING

Ningbo No. 2 Hospital ( Site 2124)

Ningbo, Zhejiang, 315010, China

RECRUITING

Centre de Cancérologie du Grand Montpellier ( Site 1016)

Montpellier, Languedoc-Roussillon, 34070, France

RECRUITING

Evangelismos General Hospital of Athens ( Site 1204)

Athens, Attica, 106 76, Greece

RECRUITING

Errikos Dunant Hospital Center ( Site 1201)

Athens, Attica, 115 26, Greece

RECRUITING

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

Athens, Attica, 115 27, Greece

RECRUITING

Athens Medical Center ( Site 1202)

Athens, Attica, 151 25, Greece

RECRUITING

Metaxa Cancer Hospital of Piraeus ( Site 1207)

Piraeus, Attica, 185 37, Greece

RECRUITING

G. Papanikolaou General Hospital ( Site 1203)

Thessaloniki, Central Macedonia, 570 10, Greece

RECRUITING

Queen Mary Hospital ( Site 3100)

Hong Kong, Hong Kong

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1400)

Milan, Lombardy, 20133, Italy

RECRUITING

National Cancer Center ( Site 3603)

Goyang-si, Kyonggi-do, 10408, South Korea

RECRUITING

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

Suwon, Kyonggi-do, 16247, South Korea

RECRUITING

Keimyung University Dongsan Hospital ( Site 3605)

Daegu, Taegu-Kwangyokshi, 42601, South Korea

RECRUITING

Severance Hospital Yonsei University Health System ( Site 3601)

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center ( Site 3600)

Seoul, 05505, South Korea

RECRUITING

Hospital Insular de Gran Canaria ( Site 1704)

Las Palmas de Gran Canaria, Canary Islands, 35016, Spain

RECRUITING

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

Girona, Gerona, 17007, Spain

RECRUITING

Hospital Puerta de Hierro ( Site 1705)

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Universitari Vall d'Hebron ( Site 1700)

Barcelona, 08035, Spain

RECRUITING

Hospital Clinico San Carlos ( Site 1706)

Madrid, 28040, Spain

RECRUITING

Hospital Universitario la Paz ( Site 1710)

Madrid, 28046, Spain

RECRUITING

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1707)

Madrid, 28223, Spain

RECRUITING

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

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Virgen Macarena ( Site 1709)

Seville, 41009, Spain

RECRUITING

Taipei Medical University Shuang Ho Hospital ( Site 3700)

New Taipei City, 235, Taiwan

RECRUITING

National Cheng Kung University Hospital ( Site 3706)

Tainan, 704, Taiwan

RECRUITING

Mackay Memorial Hospital ( Site 3701)

Taipei, 10449, Taiwan

RECRUITING

Tri-Service General Hospital ( Site 3708)

Taipei, 11490, Taiwan

RECRUITING

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

Adana, 01250, Turkey (Türkiye)

RECRUITING

Adana Medical Park Seyhan Hastanesi ( Site 1827)

Adana, 1140, Turkey (Türkiye)

RECRUITING

Ankara Atatürk Sanatoryum Eğitim ve Araştırma Hastanesi ( Site 1825)

Ankara, 06280, Turkey (Türkiye)

RECRUITING

Hacettepe Universite Hastaneleri ( Site 1810)

Ankara, 06410, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Şehir Hastanesi ( Site 1811)

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Liv Hospital Ankara ( Site 1828)

Ankara, 6680, Turkey (Türkiye)

RECRUITING

Kartal Lütfi Kırdar Şehir Hastanesi ( Site 1826)

Istanbul, 34865, Turkey (Türkiye)

RECRUITING

İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 1815)

Malatya, 44280, Turkey (Türkiye)

RECRUITING

Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 1824)

Mersin, 33240, Turkey (Türkiye)

RECRUITING

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

Rize, 53020, Turkey (Türkiye)

RECRUITING

Sakarya Egitim ve Arastırma Hastanesi ( Site 1817)

Sakarya, 54100, Turkey (Türkiye)

RECRUITING

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

Cherkasy, Cherkasy Oblast, 18009, Ukraine

RECRUITING

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

Chernivtsi, Chernivetska Oblast, 58013, Ukraine

RECRUITING

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

Kryvyi Rih, Dnipropetrovsk Oblast, 50000, Ukraine

RECRUITING

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

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

RECRUITING

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

Kropyvnytskyi, Kirovohrad Oblast, 25006, Ukraine

RECRUITING

Ukrainian Center of Tomotherapy ( Site 1917)

Kropyvnytskyi, Kirovohrad Oblast, 25011, Ukraine

RECRUITING

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

Lviv, Lviv Oblast, 79031, Ukraine

RECRUITING

Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 1902)

Lviv, Lviv Oblast, 79059, Ukraine

RECRUITING

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

Odesa, Odesa Oblast, 65025, Ukraine

RECRUITING

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

Rivne, Rivne Oblast, 33010, Ukraine

RECRUITING

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

Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

RECRUITING

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

Lutsk, Volyn Oblast, 43018, Ukraine

RECRUITING

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

Kyiv, 03057, Ukraine

RECRUITING

Shalimov Institute of Surgery and Transplantation ( Site 1907)

Kyiv, 03126, Ukraine

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 25, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): October 26, 2039
• Study Completion (Estimated): October 26, 2039
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

AR (4); HK (1); CN (13); KR (5); UA (14); CA (2); TW (4); ES (9); TU (11); FR (1); GR (6); IT (1); AU (1)