NCT06173505

Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC

A Phase 1b/2, Open-label, Randomized Study of Vudalimab in Combination With Chemotherapy or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Xencor, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify the recommended dose of vudalimab to be used in combination with chemotherapy (Part 1) and to evaluate the efficacy and safety of vudalimab plus standard of care chemotherapy relative to pembrolizumab plus chemotherapy (Part 2) as first-line treatment in patients with nonsquamous non-small cell lung cancer (NSCLC).

Detailed description

This is a Phase 1b/2 study, multicenter, open-label, randomized study in patients with nonsquamous non-small cell lung cancer without prior treatment for metastatic disease. Part 1 is designed to identify the recommended Phase 2 dose (RP2D) of vudalimab, an anti-PD-1/CTLA-4 bispecific antibody, in combination with standard of care (SOC) chemotherapy. Part 2 will evaluate the efficacy and safety vudalimab, at the RP2D, plus SOC relative to pembrolizumab (anti-PD-1) plus SOC chemotherapy.

Conditions

• Nonsquamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Vudalimab + Carboplatin + Pemetrexed	Vudalimab intravenous + carboplatin intravenous + pemetrexed intravenous
COMBINATION_PRODUCT	Pembrolizumab + Carboplatin + Pemetrexed	Pembrolizumab intravenous + carboplatin intravenous + pemetrexed intravenous

Timeline

• Start date: 2023-12-27
• Primary completion: 2025-12-24
• Completion: 2025-12-29
• First posted: 2023-12-15
• Last updated: 2026-03-13

Locations

17 sites across 8 countries: United States, Belgium, Greece, Malaysia, Netherlands, Portugal, Spain, Taiwan

Regulatory

• FDA-regulated drug study