NCT05298423

Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006)

Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 611 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab.

Detailed description

As of protocol amendment 4, participants receiving combination vibostolimab and pembrolizumab (MK-7684A) discontinued treatment due to lack of efficacy observed in other MK-7684A studies, and are given the option to transition to durvalumab therapy.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
BIOLOGICAL	pembrolizumab/vibostolimab	Administered as an intravenous (IV) infusion
BIOLOGICAL	durvalumab	Administered as an IV infusion
DRUG	cisplatin	Cisplatin 75 mg/m\^2 administered as an IV infusion in combination with pemetrexed on Day 1 of Cycles 1-3 for non-squamous histology only; In combination with etoposide, cisplatin 50 mg/m\^2 is administered on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3
DRUG	pemetrexed	Pemetrexed 500 mg/m\^2 administered as an IV infusion on Day 1 of Cycles 1-3 for non-squamous histology only
DRUG	etoposide	Etoposide 50 mg/m\^2 is administered as an IV infusion on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3;
DRUG	carboplatin	Carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3, administered as an IV infusion
DRUG	paclitaxel	Paclitaxel 200 mg/m\^2 on Day 1 of Cycle 1 and 45 mg/m\^2 on Days 1, 8, 15 of Cycles 2-3, administered as an IV infusion
RADIATION	thoracic radiotherapy	60 Gray \[Gy\] in 2 Gy fractions for 30 days total administered as an external beam radiation

Timeline

• Start date: 2022-05-03
• Primary completion: 2026-08-19
• Completion: 2026-08-19
• First posted: 2022-03-28
• Last updated: 2025-08-01

Locations

160 sites across 25 countries: United States, Argentina, Australia, Brazil, Chile, China, Costa Rica, Czechia, Dominican Republic, Germany, Greece, Guatemala, Israel, Italy, Japan, Malaysia, Mexico, Philippines, Portugal, Romania, South Africa, South Korea, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study