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Clinical Trial Summary

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.


Clinical Trial Description

PRIMARY OBJECTIVES: I. Assess the safety and tolerability of MRX-2843 (MRX-2843) when administered along with osimertinib. II. Establish the recommended phase 2 dose (RP2D) of the tested combinations. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. To perform biomarker profiling in order to identify potential predictive biomarker to optimize treatment efficacy. OUTLINE: This is a dose-escalation study of MRX-2843. Patients receive osimertinib orally (PO) once daily (QD) and MRX-2843 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for minimum of 30 days, or until resolution of treatment-related toxicity to =< grade 1, whichever is longer after removal from study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04762199
Study type Interventional
Source Emory University
Contact Conor Steuer, MD
Phone 404-727-5658
Email csteuer@emory.edu
Status Recruiting
Phase Phase 1
Start date February 24, 2021
Completion date December 27, 2025

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