Dose Escalation Trial of the Combination of Osimertinib and Quaratusugene Ozeplasmid Gene Therapy in Patients with Advanced NSCLC.
Alexander I Spira, David Berz, Robert M Jotte...
https://pubmed.ncbi.nlm.nih.gov/41385873Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID04486833
A Phase 1/2 Study of Quaratusugene Ozeplasmid with Osimertinib in Patients with Advanced EGFR-Mutant Non-Small Cell Lung Cancer
Led by Genprex, Inc. · Updated on 2026-01-21
158
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of quaratusugene ozeplasmid (Reqorsa) combined with osimertinib in patients with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations and has progressed despite osimertinib treatment. This study includes a Phase 1 dose escalation and two Phase 2 portions to assess safety and treatment response. Quaratusugene ozeplasmid is the first systemic gene therapy for cancer, using lipid nanoparticles to deliver a tumor suppressor gene. Participants receive different treatments depending on the study phase. In Phase 1 and Phase 2a, all patients receive intravenous quaratusugene ozeplasmid every 21 days plus daily oral osimertinib tablets. In Phase 2b, patients are randomly assigned to receive either this combination or standard platinum-based chemotherapy until disease progression or unacceptable side effects. Local therapies like radiation may be given before enrollment. During the study, participants undergo regular evaluations including scans and laboratory tests to monitor tumor response and safety. The main outcomes measured are the recommended dose from Phase 1, overall response rate after about 3 months, and progression-free survival after about 11 months. Researchers also track adverse events and drug levels in the body. The study includes safety monitoring and continues until disease progression or toxicity occurs.
CONDITIONS
Brief Title
Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
Who Can Participate
Age: 18Years +
All Genders
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
- NSCLC must have EGFR mutations confirmed by recent tissue biopsy or circulating tumor DNA
- Clinical response to osimertinib for at least 4 months with a minimum 10-day osimertinib washout before enrollment
- Radiological progression on osimertinib as most recent treatment, measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
- At least 28 days since major surgery without wound complications
- Stable or regressed asymptomatic brain metastases meeting specific criteria
- Willingness to provide tumor tissue for central laboratory analysis
- Adequate blood counts, kidney, liver, and heart function within 28 days
- Negative pregnancy test for females of childbearing potential within 7 days
- Agreement to use contraception for females and males with partners of childbearing potential
- Signed informed consent
You will not qualify if you...
- Unable to tolerate osimertinib leading to early discontinuation or dose changes
- Previous gene therapy
- Presence of other genetic mutations suitable for approved targeted therapies
- Radiotherapy to skull, spine, thorax, or pelvis within 30 days
- Active cancers other than NSCLC requiring systemic therapy
- Active systemic infections requiring treatment
- Serious illnesses or conditions preventing study compliance
- History of heart attack or unstable angina within 6 months
- Known HIV or active hepatitis infection
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 21-day treatment cycles until disease progression or unacceptable toxicity
Participants receive either quaratusugene ozeplasmid plus osimertinib or platinum-based chemotherapy until disease progression or unacceptable toxicity. Quaratusugene ozeplasmid is administered intravenously once every 21 days and osimertinib is taken daily as an oral tablet.
1 visit every 21 days
Follow-up
Duration - Up to approximately 21 months
Participants are monitored for safety, disease progression, and overall survival after treatment ends.
Visits scheduled according to protocol for safety and disease assessments
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
Loading map...
Research Team
S
Sr Director, Clinical Operations
C
Chief Medical Officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here