Stage IV Lung Cancer AJCC v8 Clinical Trial
Official title:
A Phase 1b Safety and Pharmacodynamic Study of MER Tyrosine Kinase Inhibitor, MRX-2843, in Combination With Osimertinib in Advanced EGFR Mutant Non-Small Cell Lung Cancer
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.
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. ;
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