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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)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517337-41-00
Enrollment
36
Registered
2026-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Completely resected Stage IIA-IIIB (N2) KRAS G12C mutated NSCLC

Brief summary

Disease-Free Survival (DFS)

Detailed description

Overall Survival (OS), Distant Metastasis-Free Survival (DMFS), Lung Cancer Specific Survival (LCSS), Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Dyspnea (Item 8) Score, Change from Baseline in the EORTC-Quality of Life Questionnaire-Lung Cancer 24 (QLQ-LC24) Coughing (Items 31 and 52) Combined Score, Change from Baseline in the EORTC-QLQ-LC24 Chest Pain (Item 40) Score, Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE

Interventions

DRUGCARBOPLATIN
DRUGPEMETREXED
DRUGCISPLATIN
DRUGPlacebo for MK-1084

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Disease-Free Survival (DFS)

Secondary

MeasureTime frame
Overall Survival (OS), Distant Metastasis-Free Survival (DMFS), Lung Cancer Specific Survival (LCSS), Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Dyspnea (Item 8) Score, Change from Baseline in the EORTC-Quality of Life Questionnaire-Lung Cancer 24 (QLQ-LC24) Coughing (Items 31 and 52) Combined Score, Change from Baseline in the EORTC-QLQ-LC24 Chest Pain (Item 40) Score, Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 21, 2026