OncoMatch/Clinical Trials/NCT04486833
Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
Is NCT04486833 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including quaratusugene ozeplasmid and osimertinib for carcinoma, non-small cell lung.
Treatment: quaratusugene ozeplasmid · osimertinib · Platinum-Based Chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR any mutation
The NSCLC must be epidermal growth factor receptor (EGFR) mutation positive-positive based on results from most recent tissue biopsy or most recent evaluation of circulating tumor DNA.
Excluded: ALK any mutation
Other genetic characteristics (such as ALK, ROS, BRAF V600E mutations) which make them a candidate for treatment with other approved targeted therapies.
Excluded: ROS1 any mutation
Other genetic characteristics (such as ALK, ROS, BRAF V600E mutations) which make them a candidate for treatment with other approved targeted therapies.
Excluded: BRAF V600E
Other genetic characteristics (such as ALK, ROS, BRAF V600E mutations) which make them a candidate for treatment with other approved targeted therapies.
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: egfr tyrosine kinase inhibitor (osimertinib)
Cannot have received: gene therapy
Lab requirements
Blood counts
ANC >1500/mm3, platelet count >100,000/mm3 within ≤28 days
Kidney function
serum creatinine ≤1.5 mg/dL or calculated creatinine clearance >50 ml/min within ≤28 days
Liver function
serum bilirubin <1.5 mg/dL and AST/ALT ≤2.5 X ULN within ≤28 days
Cardiac function
Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤28 days
ANC >1500/mm3, platelet count >100,000/mm3 within ≤28 days. Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance >50 ml/min within ≤28 days. Adequate hepatic function as documented by serum bilirubin <1.5 mg/dL and AST/ALT ≤2.5 X ULN within ≤28 days. Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤28 days.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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