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

Study acronym: KANDLELIT-013
StatusRecruiting
PhasePhase 3
Started2026-03-18
View on ClinicalTrials.gov ↗

Amendment history

2026-09-22
Trial sites expanded: 101 → 106 locations
2026-09-10
Study Status, Contacts/Locations v21
Trial sites expanded: 106 → 110 locations
Trial sites expanded: 95 → 101 locations
2026-08-27
Study Status, Contacts/Locations v20
Trial sites expanded: 86 → 95 locations
2026-08-13
Study Status, Contacts/Locations v19
Trial sites expanded: 82 → 86 locations
2026-08-12
Study Identification, Study Status v18
Re-verified, no change to tracked fields
2026-08-06
Study Status, Contacts/Locations v17
Trial sites expanded: 79 → 82 locations
2026-07-30
Study Status, Contacts/Locations v16
Trial sites expanded: 72 → 79 locations
2026-07-23
Study Status, Contacts/Locations v15
Trial sites expanded: 69 → 72 locations
2026-07-17
Study Status, Contacts/Locations v14
Trial sites expanded: 65 → 69 locations
2026-07-08
Study Status, Contacts/Locations v13
Trial sites expanded: 59 → 65 locations
2026-07-02
Study Status, Contacts/Locations v12
Study sites58→59
2026-06-25
Study Status, Contacts/Locations v11
Study sites56→58
2026-06-17
Study Status, Contacts/Locations v10
Trial sites expanded: 49 → 56 locations
2026-06-10
Study Status, Contacts/Locations v9
Trial sites expanded: 36 → 49 locations
2026-06-01
Study Status, Oversight, Contacts/Locations v8
Trial sites expanded: 24 → 36 locations
2026-05-07
Study Status, Contacts/Locations v7
Trial sites expanded: 17 → 24 locations
2026-04-30
Study Status, Contacts/Locations v6
Study sites16→17
2026-04-24
Study Status, Contacts/Locations v5
Study sites14→16
2026-04-16
Study Status, Contacts/Locations v4
Trial sites expanded: 1 → 14 locations
2026-04-08
Study Identification, Study Status, Study Description, Arms and Interventions v3
InterventionsMK-1084 (Drug), MK-3475A (Biological), Placebo (Drug)→Calderasib (Drug), MK-3475A (Biological), Placebo (Drug)
Study title+13 characters
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
2026-04-02
Study Status v2
Re-verified, no change to tracked fields
2026-03-30
Study Status, Contacts/Locations v1
Recruitment opened
Start dateestimated 2026-04-01→confirmed 2026-03-18
Study sites0→1
2026-02-19
Original filing
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.
Trial Details
NCT Number NCT07431827
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Non-small Cell Lung Cancer
Enrollment 400 participants
Start Date 2026-03-18
Primary Completion 2039-10-26 (estimated)
Study Completion 2039-10-26 (estimated)
Updated on ClinicalTrials.gov 2026-10-01