Phase 12 Study Evaluating Oral VRN110755 in Adults with EGFR-Mutant Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are studying VRN110755, a selective oral drug targeting epidermal growth factor receptor EGFR mutations in patients with EGFR-mutant non-small cell lung cancer NSCLC. This Phase 12 multicenter trial aims to evaluate the safety, tolerability, how the drug is processed in the body, and its antitumor activity, including in patients who have developed resistance to previous EGFR inhibitor treatments. The study includes dose-escalation, dose-expansion, and further evaluation phases to find the best dose and assess preliminary effectiveness. Participants receive VRN110755 as a daily oral capsule in 28-day cycles. The study has three parts Phase 1a uses a dose-escalation design to find the maximum tolerated dose and evaluate safety and early antitumor response Phase 1b expands treatment to specific patient groups based on EGFR mutation types to confirm safety and choose the recommended dose for Phase 2 Phase 2 then further assesses the drugs safety and effectiveness in selected groups. Treatment continues until disease progression, unacceptable side effects, withdrawal, or other study endpoints. Throughout the study, participants undergo regular assessments including physical exams, vital signs, laboratory tests, eye exams, ECGs, and performance status evaluations. Researchers measure pharmacokinetics, tumor response, progression-free and overall survival, and monitor adverse events. These evaluations may continue for up to six years, providing detailed information on the drugs effects and safety over time.

A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer