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

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519671-26-00

Acronym

DS3201-330

Enrollment

Registered

2025-09-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Metastatic Non-Small Cell Lung Cancer

Brief summary

Phase 1b only: Number of Participants with Dose-Limiting Toxicities, Treatment-Emergent Adverse Events, and other safety parameters during the trial., Phase 2 only: Progression-Free survival by blinded independent central review (BICR).

Detailed description

Phase 2 only: Objective Response Rate (ORR) by BICR, Phase 2 only: Duration of Response (DoR) by BICR, Phase 2 only: Disease Control Rate (DCR) by BICR, Phase 2 only: Overall Survival (OS), Phase 2 only: Progression-Free Survival by Investigator

Interventions

DRUGValemetostat Tosylate

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 1b only: Number of Participants with Dose-Limiting Toxicities, Treatment-Emergent Adverse Events, and other safety parameters during the trial., Phase 2 only: Progression-Free survival by blinded independent central review (BICR).	—

Secondary

Measure	Time frame
Phase 2 only: Objective Response Rate (ORR) by BICR, Phase 2 only: Duration of Response (DoR) by BICR, Phase 2 only: Disease Control Rate (DCR) by BICR, Phase 2 only: Overall Survival (OS), Phase 2 only: Progression-Free Survival by Investigator	—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026