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

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 c

Trial Details

NCT ID
NCT04486833
Phase
PHASE1 / PHASE2
Sponsor
Genprex, Inc.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • quaratusugene ozeplasmid
  • osimertinib
  • Platinum-Based Chemotherapy
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Lone Tree, Colorado, United States|39.55171,-104.8863
  • Urbana, Illinois, United States|40.11059,-88.20727
  • Lexington, Kentucky, United States|37.98869,-84.47772
  • Rockville, Maryland, United States|39.084,-77.15276

Key Eligibility Criteria

  • Age ≥18 years.
  • Histologically or cytologically documented NSCLC.
  • Stage III or IV NSCLC or recurrent NSCLC that is not potentially curable by radiotherapy or surgery.
  • The NSCLC must be epidermal growth factor receptor (EGFR) mutation positive-positive based on results from most recent tissue biopsy or most recent…

For full eligibility, visit ClinicalTrials.gov.

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