NCT06644768

A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations

A Multicenter, Randomized, Open-Label, Phase 1b/2 Trial Of Valemetostat Tosylate Plus Pembrolizumab Vs Pembrolizumab Alone in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1 With Tumor Proportion Score ≥50% Without Actionable Genomic Alterations

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 137 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in First-line NSCLC Without Actionable Genomic Alterations

Detailed description

This trial will evaluate the safety and efficacy of valemetostat tosylate (DS-3201b) in combination with fixed-dose pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic NSCLC without actionable genomic alterations, whose tumor has PD-L1 TPS ≥50%, and who have not received prior systemic therapy for advanced or metastatic NSCLC. The trial will be in 2 phases, dose escalation and dose expansion phases.

Conditions

• Non-small Cell Lung Cancer
• Lung Cancer

Interventions

Type	Name	Description
DRUG	valemetostat tosylate	Valemetostat will be administered orally once daily until RP2D of valemetostat is determined.
DRUG	pembrolizumab	One IV infusion Q3W on D1 of each 21-day cycle for a maximum of 35 cycles.

Timeline

• Start date: 2024-10-30
• Primary completion: 2028-03-30
• Completion: 2030-04-30
• First posted: 2024-10-16
• Last updated: 2025-10-09

Locations

45 sites across 6 countries: United States, Argentina, Brazil, China, Japan, South Korea

Regulatory

• FDA-regulated drug study