Phase II Trial of Regorafenib and Oral Methotrexate in Previously Treated Advanced <i>KRAS</i>-Mutant NSCLC.

ABSTRACT:

Introduction

There are no standard targeted treatment options for advanced KRAS-mutant NSCLC beyond KRAS G12C inhibitors. A computational model identified regorafenib and low-dose methotrexate as synergistic in preclinical models of KRAS-mutant NSCLC. This study evaluated the efficacy and safety of the combination in previously treated advanced KRAS-mutant NSCLC.

Methods

This single-arm phase II study included regorafenib 80 to 120 mg oral daily and oral methotrexate dose escalated to tolerability from 10 to 20 mg twice weekly during the first cycle. Both agents were administered on weeks 1 to 3 of each 4-week cycle. The primary end point was progression-free survival.

Results

In total, 18 patients with KRAS-mutant NSCLC were enrolle

SUBMITTER: Aredo JV 

PROVIDER: S-EPMC11609302 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature