MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More Merck Sharp & Dohme LLC trials in South Korea
Other trials for the same condition
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