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 (Jun 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
Treatments studied
Immunotherapy
Other
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 →Frequently asked questions
Is NCT06644768 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require ROS1?
Yes, ROS1 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify