TUSC2-nanoparticles (GPX-001) and Osimertinib in Patients With Stage IV Lung Cancer Who Progressed on Osimertinib Alone
Status:
Recruiting
Trial end date:
2025-08-01
Target enrollment:
Participant gender:
Summary
The purpose of this randomized study is to determine the safety and efficacy of GPX-001 a.k.a
REQORSA (a TUSC2, tumor suppressor gene, encapsulate by non-viral lipid nanoparticles) added
to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on
treatment with osimertinib.
The study will be conducted in 2 phases, a Dose Escalation Phase (Phase 1) and an Expansion
Phase (Phase 2). In Phase 1, patients will be enrolled in sequential cohorts treated with
successively higher doses of GPX-001 in combination with osimertinib. In Phase 2, patient
will be randomized to receive GPX-001 plus osimertinib or osimertinib alone.