A Study of Valemetostat Tosylate Plus Pembrolizumab for Lung Cancer
This study is for people with advanced non-small cell lung cancer (NSCLC) that has not spread and does not have certain genetic changes. It compares two treatments: valemetostat tosylate plus pembrolizumab (an immunotherapy that helps your immune system fight cancer) versus pembrolizumab alone. Researchers want to see how safe these treatments are and how well they prevent the cancer from growing. To join, you must be at least 18 years old and have not received prior treatment for advanced NSCLC. The study is currently unclear on its recruitment status, but plans to enroll 137 participants.
- Study design
- This interventional study plans to enroll 137 participants. It will compare two treatment groups: valemetostat tosylate plus pembrolizumab versus pembrolizumab alone.
- What's involved
- Pembrolizumab will be given through an IV every three weeks for up to 35 cycles. Valemetostat will be taken by mouth once daily until the best dose is found.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for side effects for 30 days after their last dose, up to approximately 31 months. They will also be checked for cancer progression up to approximately 31 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations
At a glance
Conditions
Where it's being run
35 sites across 11 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Phase 1b: Number of Participants with Dose-Limiting ToxicitiesFrom 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 EventsFrom 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 BICRFrom 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.