RecruitingPhase 1Phase 2NCT04486833

Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib

A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination With Osimertinib in Patients With Advanced, Metastatic EGFR-Mutant, Metastatic Non-Small Cell Lung Cancer

Sponsor

Genprex, Inc.

Enrollment

158 participants

Start Date

Sep 3, 2021

Study Type

INTERVENTIONAL

Conditions

Carcinoma, Non-Small Cell Lung

Summary

The purpose of this randomized study is to determine the safety and efficacy of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib. Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene and is the first systemic gene therapy for cancer. The study is comprised of a Phase 1 dose escalation portion and two Phase 2 portions evaluating safety and efficacy. Enrollment in the Phase 1 dose escalation portion is complete and the recommended Phase 2 dose (RP2D) was determined. Phase 2a has initiated and enrolled patients are treated with quaratusugene ozeplasmid at the RP2D in combination with osimertinib. In Phase 2b, patients will be randomized to receive either quaratusugene ozeplasmid plus osimertinib or platinum-based chemotherapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a gene therapy called quaratusugene ozeplasmid (Reqorsa), which restores a tumor-suppressing gene, combined with osimertinib (a targeted lung cancer drug) for patients with advanced non-small cell lung cancer (NSCLC) that has stopped responding to osimertinib. **You may be eligible if...** - You are 18 or older with confirmed non-small cell lung cancer - Your tumor has an EGFR mutation (a specific genetic change that drives cancer growth) - You previously responded to osimertinib for at least 4 months before your cancer progressed - You completed a washout of at least 10 days from osimertinib before enrolling **You may NOT be eligible if...** - You have never received osimertinib - Your cancer progressed immediately without any response to osimertinib - You have significant lung inflammation or other severe health conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALquaratusugene ozeplasmid

Quaratusugene ozeplasmid is an experimental non-viral immunogene therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, reestablishing pathways that promote cancer cell death and modulating the immune response against cancer cells.

DRUGosimertinib

Osimertinib is a 3rd generation EGFR tyrosine kinase inhibitor (TKI) oral tablet administered daily, as indicated for treatment of patients with metastatic NSCLC whose tumors have EGFR genetic deletions or mutations.

DRUGPlatinum-Based Chemotherapy

Cisplatin and carboplatin are intravenously administered platinum agents that are combined with other cytotoxic chemotherapy agents such as pemetrexed.