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A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514500-14-00
Acronym
MK-1084-007
Enrollment
206
Registered
2025-11-27
Start date
2025-12-15
Completion date
Unknown
Last updated
2026-01-19

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

Conditions

Participants with KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC

Brief summary

Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%

Detailed description

PFS in All Participants, Overall Survival (OS) in Participants with PD-L1 TPS ≥1%, OS in All Participants, Overall Response Rate (ORR) in All Participants, ORR in Participants with PD-L1 TPS ≥1%, Duration of Response (DOR), Number of Participants Who Experienced One or More Adverse Events (AEs), Number of Participants Who Discontinued Study Treatment Due to an AE, Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) (Items 29, 30) on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30), Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30, Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13), Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13, Time to Deterioration (TTD) in GHS/QoL (Items 29, 30) on the EORTC QLQ-C30, TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30, TTD in Cough Score (Item 31) on the EORTC QLQ-LC13, TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

Interventions

DRUGPEMETREXED
DRUGCARBOPLATIN
DRUGCISPLATIN

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%

Secondary

MeasureTime frame
PFS in All Participants, Overall Survival (OS) in Participants with PD-L1 TPS ≥1%, OS in All Participants, Overall Response Rate (ORR) in All Participants, ORR in Participants with PD-L1 TPS ≥1%, Duration of Response (DOR), Number of Participants Who Experienced One or More Adverse Events (AEs), Number of Participants Who Discontinued Study Treatment Due to an AE, Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) (Items 29, 30) on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30), Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30, Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13), Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13, Time to Deterioration (TTD) in GHS/QoL (Items 29, 30) on the EORTC QLQ-C30, TTD in Dyspnea Score (Item 8) on the E

Countries

Austria, France, Germany, Greece, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed

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