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Recruiting Phase 3

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

NCT07431827 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 3
Started
2026-03-18
Last updated
2026-10-07

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Calderasib →MK-3475A →Placebo

Calderasib: MK-1084 oral tablet

MK-3475A: Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.

Placebo: Placebo oral tablet

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Disease-free Survival (DFS) — Up to ~11 years
    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.

Trial sites (112)

FacilityCityRegionStatus
Instituto Alexander Fleming ( Site 0310) Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Sanatorio Parque ( Site 0311) Rosario Santa Fe Province Recruiting
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0306) CABA Argentina Recruiting
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0309) CABA Argentina Recruiting
Northern Beaches Hospital ( Site 3009) Frenchs Forest New South Wales Recruiting
Princess Alexandra Hospital ( Site 3012) Woolloongabba Queensland Recruiting
Peninsula University Hospital ( Site 3011) Frankston Victoria Recruiting
PRONUTRIR ( Site 0425) Fortaleza Ceará Recruiting
AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0414) Vitória Espírito Santo Recruiting
Real Hospital Portugues ( Site 0418) Recife Pernambuco Recruiting
Faculdade de Medicina do ABC ( Site 0415) Santo André São Paulo Recruiting
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0424) Taubaté São Paulo Recruiting
Hospital Alemao Oswaldo Cruz ( Site 0416) São Paulo Brazil Recruiting
Moncton Hospital ( Site 0200) Moncton New Brunswick Recruiting
CIUSSS- saguenay-Lac-Saint-Jean ( Site 0216) Chicoutimi Quebec Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0219) Montreal Quebec Recruiting
Clínica MEDS La Dehesa ( Site 0509) Lo Barnechea Region M. de Santiago Recruiting
Fundación Arturo López Pérez ( Site 0501) Santiago Region M. de Santiago Recruiting
Centro de Oncología de Precisión ( Site 0503) Santiago Region M. de Santiago Recruiting
Bradford Hill ( Site 0508) Santiago Region M. de Santiago Recruiting
Peking University People's Hospital ( Site 2100) Beijing Beijing Municipality Recruiting
Beijing Cancer hospital ( Site 2106) Beijing Beijing Municipality Recruiting
Peking Union Medical College Hospital ( Site 2105) Beijing Beijing Municipality Recruiting
Chongqing University Three Gorges Hospital ( Site 2138) Chongqing Chongqing Municipality Recruiting
The First Affiliated Hospital Of Fujian Medical University ( Site 2123) Fuzhou Fujian Recruiting
Fujian Cancer Hospital ( Site 2122) Fuzhou Fujian Recruiting
Sun Yat-sen University Cancer Center ( Site 2134) Guangzhou Guangdong Recruiting
Guangxi Medical University Cancer Hospital ( Site 2115) Nanning Guangxi Recruiting
Fourth Hospital Of Hebei Medical University ( Site 2107) Hshijiazhuang Hebei Recruiting
Tongji Hospital Tongji Medical,Science & Technology ( Site 2140) Wuhan Hubei Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 2139) Wuhan Hubei Recruiting
Xiangya Hospital Central South University ( Site 2136) Changsha Hunan Recruiting
The First Affiliated Hospital of Nanchang University ( Site 2121) Nanchang Jiangxi Recruiting
Affiliated Cancer Hospital of Shandong First Medical University ( Site 2111) Jinan Shandong Recruiting
Shanghai Pulmonary Hospital ( Site 2125) Shanghai Shanghai Municipality Recruiting
Fudan University Shanghai Cancer Center ( Site 2137) Shanghai Shanghai Municipality Recruiting
Zhongshan Hospital of Fudan University ( Site 2119) Shanghai Shanghai Municipality Recruiting
West China Hospital, Sichuan University ( Site 2142) Chengdu Sichuan Recruiting
The Third Peoples Hospital Of Chengdu ( Site 2141) Chengdu Sichuan Recruiting
Sichuan Cancer hospital ( Site 2101) Chengdu Sichuan Recruiting

+ 72 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07431827 on ClinicalTrials.gov ↗ ← All trials in South Korea