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A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants with Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)​

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506074-12-00
Acronym
MK-7684A-007
Enrollment
190
Registered
2023-09-29
Start date
2022-03-22
Completion date
2025-12-23
Last updated
2025-12-23

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

Conditions

Metastatic Non-Small Cell Lung Cancer

Brief summary

Overall Survival (OS) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%

Detailed description

Overall Survival (OS), Progression-Free Survival (PFS), Objective Response Rate (ORR), Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30, Change from Baseline for Role Functioning (Items 6 and 7) Combined Score on the 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 Module (EORTC QLQ-LC13), Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13, Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30, TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ- C30, TTD in Role Functioning (Items 6 and 7) Combined Score 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, Number of Participants Who Experienced One or More Adverse Events (AEs), Number of Participants Who Discontinued Study Intervention Due to an AE, Duration of Response (DOR)

Interventions

DRUGPEMETREXED
DRUGPACLITAXEL
DRUGCISPLATIN
DRUGCARBOPLATIN
DRUGALIMTA 500 mg powder for concentrate for solution for infusion
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%

Secondary

MeasureTime frame
Overall Survival (OS), Progression-Free Survival (PFS), Objective Response Rate (ORR), Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30, Change from Baseline for Role Functioning (Items 6 and 7) Combined Score on the 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 Module (EORTC QLQ-LC13), Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13, Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30, TTD in Physical Functioning (Items 1-5) Combin

Countries

Austria, France, Germany, Poland, Spain

Outcome results

None listed

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