Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

Summary

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

Official Title

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

Details

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.

Keywords

Non-small Cell Lung Cancer, Lung Cancer, NSCLC, Tumor, pembrolizumab, valemetostat tosylate, DS-3201b, Immune checkpoint inhibitor, Programmed Cell Death 1 Ligand 1, MK-3475, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Pembrolizumab + Valemetostat Tosylate

Eligibility

Locations

  • University of California San Diego (Ucsd)-Moores Cancer Center not yet accepting patients
    La Jolla California 92037 United States
  • Valkyrie Clinical Trials accepting new patients
    Los Angeles California 90067 United States
  • California Research Institute accepting new patients
    Los Angeles California 90027 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo
ID
NCT06644768
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 137 study participants
Last Updated