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
Daiichi Sankyo
Summary
This study will compare Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in First-line NSCLC Without Actionable Genomic Alterations
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. 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…
Interventions
- Drugvalemetostat tosylate
Valemetostat will be administered orally once daily until RP2D of valemetostat is determined.
- Drugpembrolizumab
One IV infusion Q3W on D1 of each 21-day cycle for a maximum of 35 cycles.
Locations (45)
- University of California San Diego (Ucsd)-Moores Cancer CenterLa Jolla, California
- California Research InstituteLos Angeles, California
- Valkyrie Clinical TrialsLos Angeles, California
- Mayo Clinic HospitalJacksonville, Florida
- BRCR GlobalPlantation, Florida
- University of Kentucky Medical CenterLexington, Kentucky