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Recruiting Phase 3 NCT07431827

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

Phase 3 – large-scale trial before approval
Conditions: Non-small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Calderasib
DRUG
MK-3475A
BIOLOGICAL
Placebo
DRUG
Locations 14
Taiwan (1)
National Cheng Kung University Hospital ( Site 3706)
Tainan
Study Coordinator
Ukraine (13)
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 1904)
Cherkasy , Cherkasy Oblast
Study Coordinator
Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 1909)
Chernivtsi , Chernivetska Oblast
Study Coordinator
Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio ( Site 1900)
Ivano-Frankivsk , Ivano-Frankivsk Oblast
Study Coordinator
Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 1916)
Kropyvnytskyi , Kirovohrad Oblast
Study Coordinator
Ukrainian Center of Tomotherapy ( Site 1917)
Kropyvnytskyi , Kirovohrad Oblast
Study Coordinator
Medical Center "Mriya Med-Service" ( Site 1911)
Kryvyi Rih , Dnipropetrovsk Oblast
Study Coordinator
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1915)
Kyiv
Study Coordinator
Shalimov Institute of Surgery and Transplantation ( Site 1907)
Kyiv
Study Coordinator
Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council ( Site 1914)
Lutsk , Volyn Oblast
Study Coordinator
Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 1908)
Lviv , Lviv Oblast
Study Coordinator
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 1902)
Lviv , Lviv Oblast
Study Coordinator
ME "Rivne Regional Antitumor Center" Rivne Regional Council ( Site 1912)
Rivne , Rivne Oblast
Study Coordinator
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 1903)
Vinnytsia , Vinnytsia Oblast
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
18.03.2026
Completion date
26.10.2039
Registry ID
NCT07431827
Source
clinicaltrials.gov
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