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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · September 16, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT04486833). This is a study registration, not published results. Lead sponsor: Genprex, Inc.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 158 participants (ESTIMATED). Conditions: Carcinoma, Non-Small Cell Lung. Interventions: BIOLOGICAL: quaratusugene ozeplasmid; DRUG: osimertinib; DRUG: Platinum-Based Chemotherapy. Primary outcome measures: Recommended Phase 2 Dose (RP2D) - Phase 1 , First 21-day treatment cycle for each dose level cohort; Overall Response Rate (ORR) - Phase 2a , Approximately 3 months; Progression-free Survival (PFS) - Phase 2b , Approximately 11 months. Brief 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.