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MK-3475A±MK-1084 in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Sponsor: Merck Sharp & Dohme LLC
Summary
This is a phase 3, randomized, double-blind study of adjuvant MK-1084 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 MK-1084 plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.
Official title: A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 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 (KANDLELIT-013)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-03-18
Completion Date
2039-10-26
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
MK-1084
MK-1084 oral tablet
MK-3475A
Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.
Placebo
Placebo oral tablet
Locations (1)
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital
Lviv, Ukraine