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RECRUITING
NCT07431827
PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

MK-1084

MK-1084 oral tablet

BIOLOGICAL

MK-3475A

Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.

DRUG

Placebo

Placebo oral tablet

Locations (1)

Lviv Territorial Medical Union Multidisciplinary Clinical Hospital

Lviv, Ukraine