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A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507776-42-00
Acronym
MK-1084-004
Enrollment
194
Registered
2024-06-10
Start date
2024-11-14
Completion date
Unknown
Last updated
2025-12-19

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

Conditions

Non-small cell lung cancer

Brief summary

1. Progression-free survival (PFS), 2. Overall survival (OS)

Detailed description

1. Objective response rate (ORR), 2. Duration of response (DOR), 3. Number of participants who experience one or more Adverse Events (AEs), 4. Number of participants who discontinue study treatment due to an AE, 5. Change from baseline in global health status/quality of life (items 29 and 30) score, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), 6. Change from baseline in the physical functioning (items 1-5) score, on the EORTC QLQ-C30, 7. Change from baseline in the role functioning (items 6-7) score, on the EORTC QLQ-C30, 8. Change from baseline in the dyspnea (item 8) score, on the EORTC QLQ-C30, 9. Change from baseline in the cough (item 31) score, on the EORTC QLQ- LC13, 10. Change from baseline in the chest pain (item 40) score, on the EORTC QLQ-LC13, 11. Time to deterioration (TTD) in global health status/quality of life (items 29 and 30) score, on the EORTC-QLQ-C30, 12. TTD in the physical functioning (items 1-5) score, on the EORTC-QLQ-C30, 13. TTD in the role functioning (items 6-7) score, on the EORTC QLQ-C30, 14. TTD in the dyspnea (item 8) score, on the EORTC QLQ-C30, 15. TTD in the cough (item 31) score, on the EORTC QLQ-Lung Cancer version (LC13), 16. TTD in the chest pain (item 40) score, on the EORTC QLQ-LC13

Interventions

DRUGPlacebo to MK-1084 50 mg
DRUGPlacebo to MK-1084 25 MG
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Progression-free survival (PFS), 2. Overall survival (OS)

Secondary

MeasureTime frame
1. Objective response rate (ORR), 2. Duration of response (DOR), 3. Number of participants who experience one or more Adverse Events (AEs), 4. Number of participants who discontinue study treatment due to an AE, 5. Change from baseline in global health status/quality of life (items 29 and 30) score, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), 6. Change from baseline in the physical functioning (items 1-5) score, on the EORTC QLQ-C30, 7. Change from baseline in the role functioning (items 6-7) score, on the EORTC QLQ-C30, 8. Change from baseline in the dyspnea (item 8) score, on the EORTC QLQ-C30, 9. Change from baseline in the cough (item 31) score, on the EORTC QLQ- LC13, 10. Change from baseline in the chest pain (item 40) score, on the EORTC QLQ-LC13, 11. Time to deterioration (TTD) in global health status/quality of life (items 29 and 30) score, on the EORTC-QLQ-C30, 12. TTD in the physical functioni

Countries

Austria, Bulgaria, France, Germany, Greece, Italy, Netherlands, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026