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)

Conditions

• Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• pembrolizumab/vibostolimab — BIOLOGICAL
  Administered as an intravenous (IV) infusion
• durvalumab — BIOLOGICAL
  Administered as an IV infusion
• cisplatin — DRUG
  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
• pemetrexed — DRUG
  Pemetrexed 500 mg/m\^2 administered as an IV infusion on Day 1 of Cycles 1-3 for non-squamous histology only
• etoposide — DRUG
  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;
• carboplatin — DRUG
  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
• paclitaxel — DRUG
  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
• thoracic radiotherapy — RADIATION
  60 Gray \[Gy\] in 2 Gy fractions for 30 days total administered as an external beam radiation

Study Details

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.

Key Dates

Start date

May 3, 2022

Status verified

Jul 2025

Primary completion

Aug 19, 2026

Completion

Aug 19, 2026

Study Design

Enrollment

611 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy
  For the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to \~14 months). Cycles 1-20 are 21-day cycles. As of protocol amendment 4, participants receiving pembrolizumab/vibostolimab must stop ongoing treatment with pembrolizumab/vibostolimab and will be offered the option to transition to post-cCRT durvalumab consolidation therapy, to complete up to 1 year of consolidation immunotherapy.
• Active Comparator: chemotherapy+radiotherapy+durvalumab
  For the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy during Cycles 2 and 3. Following concurrent chemoradiotherapy (cCRT), participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles.

Primary Outcome Measure

Number of Participants Who Experience at Least One Adverse Event (AE) [ Time Frame: Up to approximately 48 months ]

Locations (21)

Find similar trials in Long Beach, CA

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