Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
NCT04486833
This study is recruiting at 8 US sites in 7 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Carcinoma, Non-Small Cell Lung
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1/2
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Genprex, Inc.
- Last updated on ClinicalTrials.gov
- September 16, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 1
- Valkyrie Clinical Trials · Los Angeles, CA
Colorado · 1
- Rocky Mountain Cancer Centers · Lone Tree, CO
Illinois · 1
- Carle Cancer Institute · Urbana, IL
Kentucky · 1
- Markey Cancer Center · Lexington, KY
New Jersey · 1
- The Valley Hospital - Luckow Pavilion · Paramus, NJ
Ohio · 1
- Gabrail Cancer Center Research · Canton, OH
Virginia · 2
- Virginia Cancer Specialists · Fairfax, VA
- Virginia Oncology Associates · Norfolk, VA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.