NCT06644768 · Daiichi Sankyo
A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations
What this study is about
This study will compare Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in First-line NSCLC Without Actionable Genomic Alterations
View original scientific description
This study will compare Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in First-line NSCLC Without Actionable Genomic Alterations
Interventions
DRUG
valemetostat tosylate
Valemetostat will be administered orally once daily until RP2D of valemetostat is determined.
DRUG
pembrolizumab
One IV infusion Q3W on D1 of each 21-day cycle for a maximum of 35 cycles.
Primary outcome measures
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
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.
Phase 1b: Number of Participants with Treatment-Emergent Adverse Events
Time frame: From date of first dose to 30 days after last dose, up to approximately 31 months
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
Phase 2: Progression-Free Survival 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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Has signed and dated the ICF, prior to the start of any trial-specific qualification procedures. 2. Is an adult ≥18 years of age or the minimum legal age (whichever is greater) at the time of informed consent. (Follow local regulatory requirements if the legal age of adult voluntary consent for trial participation is \>18 years old). 3. Has histologically documented NSCLC that meets all of the following criteria: 1. Has no prior systemic therapy for advanced or metastatic disease. 2. Has Stage IIIB or IIIC disease and is not a candidate for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of enrollment/randomization (based on the American Joint Committee on Cancer, Eighth Edition). Participants with early-stage NSCLC who have relapsed should be restaged during Screening to ensure their eligibility for the trial. 3. Has documented negative test results for EGFR, ALK, and ROS1 actionable genomic alterations based
Where
- La Jolla, California
- Los Angeles, California
- Jacksonville, Florida
- Plantation, Florida
- Lexington, Kentucky
- Pikeville, Kentucky
- Rochester, Minnesota
- New York, New York
- The Bronx, New York
- Philadelphia, Pennsylvania
- Fairfax, Virginia
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2025 · Source of record for eligibility and locations