Actively Recruiting
MRX-2843 and Osimertinib for the Treatment of Advanced EGFR Mutant Non-small Cell Lung Cancer
Led by Emory University · Updated on 2026-03-31
69
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase Ib trial evaluates the best dose and side effects of MRX-2843 when given in combination with osimertinib in treating patients with EGFR gene mutant non-small cell lung cancer that has spread to other places in the body (advanced). MRX-2843 and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
CONDITIONS
Official Title
MRX-2843 and Osimertinib for the Treatment of Advanced EGFR Mutant Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic non-small cell lung cancer with activating EGFR mutations in exons 19 or 21
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Measurable disease with lesions at least 20 mm by chest x-ray or 10 mm by CT, MRI, or clinical exam (for expansion cohort patients)
- Ability to safely swallow oral medication
- Absolute neutrophil count of at least 1500/mm^3
- Platelet count of at least 100,000/mm^3
- Hemoglobin level of at least 8.5 g/dL and at least 2 weeks since last red blood cell transfusion
- Bilirubin levels less than or equal to 1.5 times the upper limit of normal (ULN), with higher limits allowed for Gilbert's disease or liver metastases
- Serum creatinine less than or equal to 1.5 times ULN or creatinine clearance of at least 50 mL/min
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than or equal to 3 times ULN, or up to 5 times ULN for liver metastases
- Use of adequate contraception for women of childbearing potential and men during and after study participation
- Negative pregnancy test for females of childbearing potential at screening and day 1 of cycles 1-6
- Ability to understand and sign informed consent
- Specific cohort criteria including prior treatment status with EGFR tyrosine kinase inhibitors
- Backfill cohort patients must meet general eligibility and other safety criteria
You will not qualify if you...
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before study entry
- Unresolved adverse events from prior anti-cancer therapy above grade 1
- Use of other investigational agents
- Symptomatic untreated brain metastases (treated or asymptomatic allowed)
- Allergic reactions to similar compounds as MRX-2843 or osimertinib
- Known interstitial lung disease or pneumonitis
- Corrected QT interval prolongation over 500 msec or related heart conditions
- Known cardiomyopathy or left ventricular ejection fraction below 50%
- History or symptoms of keratitis
- Use of medications affecting CYP450 enzymes
- Uncontrolled illnesses including active infections, heart failure, unstable angina, arrhythmia, or psychiatric conditions
- Pregnancy or breastfeeding
- HIV-positive patients on combination antiretroviral therapy
- Known or suspected retinitis pigmentosa
- History or high risk of type 1 diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
C
Conor Steuer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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