Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony nowotwór złośliwy płuc (nie drobnokomórkowy)
- •Zaawansowany lub nawracający rak płuca, którego nie można wyleczyć operacją lub radioterapią
- •Mutacja genu EGFR potwierdzona ostatnim badaniem tkanki lub krwi
- •Pozytywna odpowiedź na osimertinib przez co najmniej 4 miesiące
- •Pogorszenie choroby podczas leczenia osimertinibem
- •Dobry ogólny stan zdrowia (wynik ECOG 0-1)
- •Przeszczepia możliwości poddania się biopsji guza
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 16, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (10)
Valkyrie Clinical Trials
Los Angeles, United States
Rocky Mountain Cancer Centers
Lone Tree, United States
Carle Cancer Institute
Urbana, United States
Markey Cancer Center
Lexington, United States
Maryland Oncology Hematology
Rockville, United States
The Valley Hospital - Luckow Pavilion
Paramus, United States
Gabrail Cancer Center Research
Canton, United States
Millennium Oncology
Houston, United States
Virginia Cancer Specialists
Fairfax, United States
Virginia Oncology Associates
Norfolk, United States
Trial contact
Sr Director, Clinical Operations
Chief Medical Officer
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/17/2026.
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