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NCT04486833 · ClinicalTrials.gov registry record · Phase 1
Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
A Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Genprex.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 158
- Enrollment target
- 10
- Study locations
NCT04486833: Recruiting Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Genprex.
NCT04486833 is a Phase 1 study of Carcinoma, Non-Small Cell Lung that is actively recruiting participants, run by Genprex. The registered enrollment target is 158 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (51% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04486833, a Phase 1 study of Carcinoma, Non-Small Cell Lung, is actively recruiting participants, sponsored by Genprex.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 158 participants
- Enrollment target
- 10
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG osimertinib
- BIOLOGICAL quaratusugene ozeplasmid
- DRUG Platinum-Based Chemotherapy
Study Locations (10)
Virginia
- Virginia Cancer Specialists - Fairfax
- Virginia Oncology Associates - Norfolk
California
- Valkyrie Clinical Trials - Los Angeles
Colorado
- Rocky Mountain Cancer Centers - Lone Tree
Illinois
- Carle Cancer Institute - Urbana
Kentucky
- Markey Cancer Center - Lexington
Maryland
- Maryland Oncology Hematology - Rockville
New Jersey
- The Valley Hospital - Luckow Pavilion - Paramus
Ohio
- Gabrail Cancer Center Research - Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2021-09-03 |
| Est. Completion | 2029-03 |
| Phase | Phase 1 |
What NCT04486833 shows while recruiting
NCT04486833 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 3 interventions - of which osimertinib is the first listed.
NCT04486833 lists 10 locations in 9 states (Virginia, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT04486833 about?
NCT04486833 is a clinical study titled "Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib". 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 nanop...
What is the current status of trial NCT04486833?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 158 participants. The study started on 2021-09-03. Estimated completion is 2029-03.
What conditions does trial NCT04486833 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT04486833?
The interventions under investigation include: osimertinib (DRUG), quaratusugene ozeplasmid (BIOLOGICAL), Platinum-Based Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT04486833?
This trial is sponsored by Genprex, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04486833 being conducted?
This trial has 10 study locations across California, Colorado, Illinois, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04486833's enrollment target sits among peer trials
158 56th of 130 higher than 75 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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