A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations
← catalyst calendarNCT06644768 · readout in 589 d
Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
137estimated
Sites
35
Countries
Argentina, Brazil, China +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-10-30 | actual | When the study began enrolling |
| Primary completion | 2028-03-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-04-30 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Non-small Cell Lung Cancer
- Lung Cancer
Interventions
- Drug: valemetostat tosylate — also filed as DS-3201b, valemetostat
- Drug: pembrolizumab — also filed as MK-3475, KEYTRUDA®
Primary outcomes
what the primary-completion date above is the date OFPhase 1b: Number of Participants with Dose-Limiting Toxicities
measured From day of first dose on Day 1 to Day 21 in Cycle 1 (21 days), or before the administration of Cycle 2, up to 24 days
Phase 1b: Number of Participants with Treatment-Emergent Adverse Events
measured From date of first dose to 30 days after last dose, up to approximately 31 months
Phase 2: Progression-Free Survival by BICR
measured From date of randomization to the date of radiographic disease progression, or death from any cause, whichever occurs first, up to approximately 31 months
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