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Clinical Trials in the UK / NCT07431827
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 UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2026-03-18
Last updated
2026-09-14

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

CalderasibMK-3475APlacebo

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)

Trial sites (101)

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
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
Faculdade de Medicina do ABC ( Site 0415) Santo André 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
FALP ( Site 0501) Santiago Region M. de Santiago Recruiting
Centro de Oncología de Precisión ( Site 0503) 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
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
The Affiliated Cancer Hospital of Xinjiang Medical ( Site 2110) Urumuqi Xinjiang Recruiting
Yunnan Province Cancer Hospital ( Site 2131) Kunming Yunnan Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 2118) Hangzhou Zhejiang Recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 2103) Hangzhou Zhejiang Recruiting
Zhejiang Cancer Hospital ( Site 2117) Hangzhou Zhejiang Recruiting

+ 61 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 the UK