This study will compare Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in First-line NSCLC Without Actionable Genomic Alterations
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
137
Valemetostat will be administered orally once daily until RP2D of valemetostat is determined.
One IV infusion Q3W on D1 of each 21-day cycle for a maximum of 35 cycles.
Phase 1b: Number of Participants with Dose-Limiting Toxicities
Total number of participants with A Dose-Limiting Toxicity (DLT) at each dose level of valemetostat in combination with pembrolizumab per National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0.
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
Phase 1b: Number of Participants with Treatment-Emergent Adverse Events
Incidence of TEAEs, Grade 3 or 4 TEAEs, deaths, TESAEs, TEAEs leading to dose modifications (including interruption, reduction, and discontinuation), and AESIs using the National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0
Time frame: From date of first dose to 30 days after last dose, up to approximately 31 months
Phase 2: Progression-Free Survival by BICR
PFS is the time from the date of randomization to the date of radiographic disease progression as assessed by blinded independent central review (BICR) per RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: From date of randomization to the date of radiographic disease progression, or death from any cause, whichever occurs first, up to approximately 31 months
Phase 2: Objective Response Rate
Objective Response Rate (ORR) is the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR.
Time frame: From date of randomization to the date of radiographic disease progression, or death from any cause, whichever occurs first, up to approximately 31 months
Phase 2: Duration of Response
Duration of Response (DoR) is the time from the date of first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the date of the first documentation of objective tumor progression or to death from any cause, whichever occurs first, assessed by BICR.
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University of California San Diego (Ucsd)-Moores Cancer Center
La Jolla, California, United States
California Research Institute
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Mayo Clinic Hospital
Jacksonville, Florida, United States
BRCR Global
Plantation, Florida, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Pikeville Medical Center
Pikeville, Kentucky, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Columbia University Irving Medical Center
New York, New York, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
...and 25 more locations
Time frame: From date of randomization to the date of radiographic disease progression, or death from any cause, whichever occurs first, up to approximately 31 months
Phase 2: Disease Control Rate
Disease control rate (DCR) is the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD), assessed by BICR.
Time frame: From date of randomization up to approximately 31 months
Phase 2: Overall Survival
Overall Survival (OS ) is the time from the date of randomization to the date of death from any cause.
Time frame: From date of randomization the date of death from any cause, up to approximately 31 months
Phase 2: Progression-Free Survival by Investigator
PFS is the time from the date of randomization to the date of radiographic disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: From date of randomization to the date of radiographic disease progression, or death from any cause, whichever occurs first, up to approximately 31 months
Phase 1 and 2: Total and Unbound Plasma Concentration of Valemetostat
Time frame: Cycle 1: Day 1- Pre-dose, 2, 4, 5 hrs post-dose, Day 8- Pre-dose, Day 15- Pre-dose and post-dose. Cycles 2- 5: Day 1- Pre-dose