Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib (NCT04486833)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (26 items) and avoid the listed exclusions (11 items).
Location: Valkyrie Clinical Trials — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Unable to tolerate osimertinib treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications as determined by the Investigator.
- Received prior gene therapy.
- Other genetic characteristics (such as ALK, ROS, BRAF V600E mutations) which make them a candidate for treatment with other approved targeted therapies.
- Received radiotherapy to the skull, spine, thorax, or pelvis within ≤30 days.
- Active concurrent malignancies, i.e., cancers other than NSCLC that require systemic therapy.
- Active systemic viral, bacterial, or fungal infection(s) requiring treatment.
- Serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the Investigator, would not permit adequate follow-up and compliance with the study protocol.
- History of myocardial infarction or unstable angina within ≤6 months.
- Known human immunodeficiency virus (HIV) infection or has active hepatitis infection.
- Female who is pregnant or breastfeeding.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (10 Sites)
- Valkyrie Clinical Trials — Los Angeles, California
- Rocky Mountain Cancer Centers — Lone Tree, Colorado
- Carle Cancer Institute — Urbana, Illinois
- Markey Cancer Center — Lexington, Kentucky
- Maryland Oncology Hematology — Rockville, Maryland
- The Valley Hospital - Luckow Pavilion — Paramus, New Jersey
- Gabrail Cancer Center Research — Canton, Ohio
- Millennium Oncology — Houston, Texas
- Virginia Cancer Specialists — Fairfax, Virginia
- Virginia Oncology Associates — Norfolk, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.