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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)

NCT05298423 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 611

Last updated 2025-08-01

No results posted yet for this study

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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-03
Primary Completion
2026-08-19
Completion
2026-08-19
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05298423 on ClinicalTrials.gov