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

Part of paid clinical trials in La Jolla, California.

Sponsor
Daiichi Sankyo
Study ID
NCT06644768
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Oct 30, 2024
Status verified
Oct 2025
Primary completion
Mar 30, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
137 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: Pembrolizumab + Valemetostat Tosylate
    Participants will be provided with pembrolizumab at standard dose of 200 mg intravenously (IV) Q3W, and valemetostat will be provided per a dose escalation schedule, with an initial starting dose of 150 mg by mouth once daily.
  • Experimental: Phase 2: Pembrolizumab + Valemetostat Tosylate
    Participants will be provided with pembrolizumab at standard dose of 200 mg IV Q3W, and valemetostat will be provided per recommended phase 2 dose (RP2D)
  • Active Comparator: Phase 2: Pembrolizumab
    Participants will be provided with pembrolizumab at standard dose of 200 mg IV Q3W

Primary Outcome Measure

Phase 1b: Number of Participants with Dose-Limiting Toxicities [ Time Frame: 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 ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
University of California San Diego (Ucsd)-Moores Cancer CenterLa JollaCalifornia92037-
California Research InstituteLos AngelesCalifornia90027-
Valkyrie Clinical TrialsLos AngelesCalifornia90067-
Mayo Clinic HospitalJacksonvilleFlorida32224-
BRCR GlobalPlantationFlorida33322-5426-
University of Kentucky Medical CenterLexingtonKentucky40536-
Pikeville Medical CenterPikevilleKentucky41501-
Mayo Clinic - RochesterRochesterMinnesota55904-
Columbia University Irving Medical CenterNew YorkNew York10032-
Montefiore Medical CenterThe BronxNew York10461-
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-
Virginia Cancer SpecialistFairfaxVirginia22031-

Find similar trials in La Jolla, CA

By condition
Lung cancer
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By research site
University of California San Diego (Ucsd)-Moores Cancer Center· La Jolla, CACalifornia Research Institute· Los Angeles, CAValkyrie Clinical Trials· Los Angeles, CAMayo Clinic Hospital· Jacksonville, FLBRCR Global· Plantation, FLUniversity of Kentucky Medical Center· Lexington, KY

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