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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07431827
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Calderasib — DRUG
    MK-1084 oral tablet
  • MK-3475A — BIOLOGICAL
    Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.
  • Placebo — DRUG
    Placebo oral tablet

Study Details

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.

Key Dates

Start date
Mar 18, 2026
Status verified
May 2026
Primary completion
Oct 26, 2039
Completion
Oct 26, 2039

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Calderasib + MK-3475A
    Participants receive calderasib daily (qd) and MK-3475A every 6 weeks (q6w) for up to 9 doses.
  • Active Comparator: Placebo + MK-3475A
    Participants receive placebo qd and MK-3475A q6w for up to 9 doses.

Primary Outcome Measure

Disease-free Survival (DFS) [ Time Frame: Up to ~11 years ]

Central Contacts

Related Studies