OncoMatch/Clinical Trials/NCT06644768
A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations
Is NCT06644768 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including valemetostat tosylate and pembrolizumab for non-small cell lung cancer.
Treatment: valemetostat tosylate · pembrolizumab — This study will compare Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in First-line NSCLC Without Actionable Genomic Alterations
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR wild-type
Has documented negative test results for EGFR...actionable genomic alterations
Required: ALK wild-type
Has documented negative test results for...ALK...actionable genomic alterations
Required: ROS1 wild-type
Has documented negative test results for...ROS1 actionable genomic alterations
Required: NTRK1 wild-type
Has no known actionable genomic alterations in NTRK, BRAF, RET, MET, or other actionable oncogenic drivers with locally approved therapies
Required: NTRK2 wild-type
Has no known actionable genomic alterations in NTRK, BRAF, RET, MET, or other actionable oncogenic drivers with locally approved therapies
Required: NTRK3 wild-type
Has no known actionable genomic alterations in NTRK, BRAF, RET, MET, or other actionable oncogenic drivers with locally approved therapies
Required: BRAF wild-type
Has no known actionable genomic alterations in NTRK, BRAF, RET, MET, or other actionable oncogenic drivers with locally approved therapies
Required: RET wild-type
Has no known actionable genomic alterations in NTRK, BRAF, RET, MET, or other actionable oncogenic drivers with locally approved therapies
Required: MET wild-type
Has no known actionable genomic alterations in NTRK, BRAF, RET, MET, or other actionable oncogenic drivers with locally approved therapies
Required: PD-L1 (CD274) overexpression (TPS ≥50%)
Has a tumor expressing PD-L1 TPS ≥50% as determined by local testing using 22C3 pharmDx PD-L1 IHC assay. In regions where PD-L1 (TPS ≥50%) testing by 22C3 pharmDx is not considered SOC, PD-L1 expression levels will be determined by central testing
Allowed: KRAS mutation
Participants whose tumors harbor KRAS mutations are eligible for the trial
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-pd-1/pd-l1/pd-l2 or co-inhibitory t-cell receptor therapy
Cannot have received: enhancer of zeste homolog inhibitor
Lab requirements
Cardiac function
No uncontrolled or significant cardiovascular disease, including mean QTcF >470 ms, recent MI or angina, NYHA Class 3 or 4 CHF, or uncontrolled hypertension
Has uncontrolled or significant cardiovascular disease, including the following: Mean QT interval corrected for heart rate using Fridericia's formula >470 ms (based on the average of screening triplicate 12-lead ECG determinations); Myocardial infarction within 6 months prior to Screening; Uncontrolled angina pectoris within 6 months prior to Screening; New York Heart Association Class 3 or 4 congestive heart failure; Uncontrolled hypertension (resting systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California San Diego (Ucsd)-Moores Cancer Center · La Jolla, California
- California Research Institute · Los Angeles, California
- Valkyrie Clinical Trials · Los Angeles, California
- Mayo Clinic Hospital · Jacksonville, Florida
- BRCR Global · Plantation, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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