Study Comparing Valemetostat Tosylate and Pembrolizumab with Pembrolizumab Alone for First-Line Treatment of NSCLC Without Specific Genetic Changes
Sponsor: Daiichi Sankyo
ClinicalTrials ID:NCT06644768
This clinical trial is testing whether adding Valemetostat Tosylate to Pembrolizumab is more effective than using Pembrolizumab alone for treating advanced non-small cell lung cancer (NSCLC) without certain genetic changes.
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Program Overview
The study aims to evaluate the safety and effectiveness of combining Valemetostat Tosylate with Pembrolizumab compared to using Pembrolizumab alone in patients with advanced or metastatic non-small cell lung cancer (NSCLC) that does not have specific genetic changes. Participants must have a tumor with a PD-L1 expression of 50% or higher and should not have received previous treatment for advanced NSCLC. The trial will be conducted in two phases: dose escalation and dose expansion.
Description
This clinical trial is designed to test a new combination of cancer treatments for people with advanced non-small cell lung cancer (NSCLC) that does not have certain genetic changes. The study will compare the effects of using Valemetostat Tosylate together with Pembrolizumab against using Pembrolizumab alone. Participants must have a tumor with a PD-L1 expression of 50% or higher and should not have received any prior treatment for advanced NSCLC. The trial will be conducted in two phases: the first phase will determine the best dose of the combination treatment, and the second phase will expand the study to more participants to further evaluate its effectiveness.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that has not been treated with systemic therapy for advanced or metastatic disease.
- Have Stage IIIB, IIIC, or Stage IV NSCLC that cannot be treated with surgery or definitive chemoradiation.
- Have no known genetic changes in EGFR, ALK, ROS1, NTRK, BRAF, RET, MET, or other actionable oncogenic drivers.
- Have a tumor with PD-L1 expression of 50% or higher.
- Provide a tumor tissue sample for biomarker assessment.
- Have an ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
Exclusion Criteria
- Have received prior treatment with anti-PD-1, anti-PD-L1, or similar agents.
- Have received a live vaccine within 30 days before the first dose of the trial.
- Have an active autoimmune disease requiring treatment in the past 2 years.
- Have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy.
- Have untreated or active brain metastases or carcinomatous meningitis.
- Have significant heart disease or uncontrolled high blood pressure.
- Have a history of lung inflammation or pneumonitis that required steroids.
- Have had an organ transplant.
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