OncoMatch/Clinical Trials/NCT07252739
KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)
Is NCT07252739 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments for malignant neoplasm.
Treatment: MK-1084 · Pembrolizumab · Cetuximab · Sacituzumab tirumotecan (sac-TMT) · Rescue medication — Researchers want to learn if using a study medicine called MK-1084 can help treat Non-Small Cell Lung Cancer (NSCLC). MK-1084 is a type of treatment called targeted therapy for the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C gene change. The goal of this study is to learn about the safety of MK-1084 and to learn how many people have the cancer get smaller or go away during the study treatment.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Tumor Agnostic
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: KRAS g12c
Prior therapy
Cannot have received: systemic anticancer therapy for advanced or metastatic NSCLC
Has received prior systemic anticancer therapy for advanced or metastatic NSCLC
Cannot have received: KRAS inhibitor
Has received previous treatment with an agent targeting KRAS
Cannot have received: immunotherapy
Exception: discontinued due to Grade 3 or higher immune-related adverse event (except endocrine disorders that can be treated with replacement therapy) or due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE) (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
Lab requirements
Cardiac function
No uncontrolled, clinically significant cardiovascular disease or cerebrovascular disease, including NYHA Class III or IV CHF, unstable angina, MI, uncontrolled symptomatic arrhythmia, QTcF >470 ms, or other serious cardiovascular/cerebrovascular diseases within 6 months
uncontrolled, clinically significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval corrected for heart rate by Fridericia's formula (QTcF) interval to >470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Clermont Oncology Center ( Site 0041) · Clermont, Florida
- Sanford Health Roger Maris Cancer Center ( Site 0039) · Fargo, North Dakota
- Sanford Cancer Center Oncology Clinic ( Site 0038) · Sioux Falls, South Dakota
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07252739 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anticancer therapy for advanced or metastatic NSCLC, KRAS inhibitor, immunotherapy disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS g12c is a required biomarker for enrollment.
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 qualifyRelated pages