NCT04486833 · Genprex, Inc.
Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
(Acclaim-1)
What this study is about
The purpose of this randomly assigned study is to determine the safety and effectiveness of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib.
View original scientific description
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.
Interventions
BIOLOGICAL
quaratusugene ozeplasmid
Quaratusugene ozeplasmid is an experimental non-viral immunogene therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, reestablishing pathways that promote cancer cell death and modulating the immune response against cancer cells.
DRUG
osimertinib
Osimertinib is a 3rd generation EGFR tyrosine kinase inhibitor (TKI) oral tablet administered daily, as indicated for treatment of patients with metastatic NSCLC whose tumors have EGFR genetic deletions or mutations.
DRUG
Platinum-Based Chemotherapy
Cisplatin and carboplatin are intravenously administered platinum agents that are combined with other cytotoxic chemotherapy agents such as pemetrexed.
Primary outcome measures
Recommended Phase 2 Dose (RP2D) - Phase 1
Time frame: First 21-day treatment cycle for each dose level cohort
RP2D, which will be the maximum tolerated dose (MTD) or, if the MTD is not defined by the safety data, RP2D will be determined based on an integrated assessment of all available clinical safety and preliminary efficacy data.
Overall Response Rate (ORR) - Phase 2a
Time frame: Approximately 3 months
ORR (complete response \[CR\]+ partial response \[PR\]) according to RECIST using best overall response.
Progression-free Survival (PFS) - Phase 2b
Time frame: Approximately 11 months
PFS from randomization to disease progression or death. Response according to RECIST.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥18 years. 2. Histologically or cytologically documented NSCLC. 3. Stage III or IV NSCLC or recurrent NSCLC that is not potentially curable by radiotherapy or surgery. 4. 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. 5. Achieved clinical response to osimertinib for ≥4 months, which can be a response of stable disease. Must have a minimum of a 10-day osimertinib washout completed at the time of enrollment. 6. Must have radiological progression on osimertinib treatment and can have either asymptomatic disease or symptomatic disease. In addition: 1. Must have measurable disease per RECIST 1.1. 2. Must have progression on osimertinib treatment as a single agent or in combination with other anti-cancer agents as their most recent treatment. Notes:
- Patients may have had treatment with other EGFR inhibitors as si
Where
- Los Angeles, California
- Lone Tree, Colorado
- Urbana, Illinois
- Lexington, Kentucky
- Rockville, Maryland
- Paramus, New Jersey
- Canton, Ohio
- Houston, Texas
- Fairfax, Virginia
- Norfolk, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 21, 2026 · Source of record for eligibility and locations