Actively Recruiting
Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
Led by Genprex, Inc. · Updated on 2026-01-21
158
Participants Needed
10
Research Sites
390 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage III or IV NSCLC or recurrent NSCLC not curable by radiotherapy or surgery
- Positive for EGFR mutation based on recent biopsy or circulating tumor DNA test
- Clinical response to osimertinib for at least 4 months, including stable disease
- Completed at least a 10-day osimertinib washout before enrollment
- Radiological progression on osimertinib treatment with measurable disease per RECIST 1.1
- Received osimertinib as the most recent treatment, alone or with other anticancer agents
- ECOG performance status of 0 or 1
- At least 28 days past major surgery without wound complications
- If brain metastases are present, no seizures in past 6 months, completed treatment at least 21 days ago, off steroids for 7 days, and stable or regressing brain lesions on imaging
- Willing to provide tumor tissue for laboratory analysis
- Adequate blood counts, kidney, liver, and heart function within 28 days before enrollment
- For females of childbearing potential, negative pregnancy test within 7 days
- Agree to use two forms of contraception during and after treatment if applicable
- Males agree to no sperm donation during and after treatment
- Voluntary informed consent given
You will not qualify if you...
- Unable to tolerate osimertinib leading to early discontinuation or frequent dose changes
- Prior gene therapy treatment
- Presence of genetic mutations (ALK, ROS, BRAF V600E) suitable for other targeted therapies
- Radiotherapy to skull, spine, thorax, or pelvis within 30 days
- Active cancers other than NSCLC requiring systemic therapy
- Active infections requiring treatment
- Serious illnesses or conditions preventing study compliance
- Heart attack or unstable angina within 6 months
- Known HIV or active hepatitis infection
- Pregnant or breastfeeding females
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
2
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States, 80124
Actively Recruiting
3
Carle Cancer Institute
Urbana, Illinois, United States, 61801
Actively Recruiting
4
Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
5
Maryland Oncology Hematology
Rockville, Maryland, United States, 20850
Actively Recruiting
6
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, United States, 07652
Actively Recruiting
7
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Actively Recruiting
8
Millennium Oncology
Houston, Texas, United States, 77090
Terminated
9
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
10
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
Research Team
S
Sr Director, Clinical Operations
CONTACT
C
Chief Medical Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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