Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing quaratusugene ozeplasmid for Carcinoma, Non-Small Cell Lung

The purpose of this randomly assigned study is to determine the safety and how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT04486833 · Genprex, Inc. · enrollment listed as 158

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are quaratusugene ozeplasmid, osimertinib, or Platinum-Based Chemotherapy. The registry lists allocation as randomized. The purpose of this randomly assigned study is to determine the safety and how well it works of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib.

They plan to enroll about 158 people at 10 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination With Osimertinib in Patients With Advanced, Metastatic EGFR-Mutant, Metastatic Non-Small Cell Lung Cancer

Interventions: quaratusugene ozeplasmid, osimertinib, Platinum-Based Chemotherapy

Primary outcome (registry wording): Recommended Phase 2 Dose (RP2D) - Phase 1

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Histologically or cytologically documented NSCLC
  • Stage III or IV NSCLC or recurrent NSCLC that is not potentially curable by radiotherapy or surgery
  • 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
  • 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
  • Must have radiological progression on osimertinib treatment and can have either asymptomatic disease or symptomatic disease. In addition:
  • Must have measurable disease per RECIST 1.1
  • Must have progression on osimertinib treatment as a single agent or in combination with other anti-cancer agents as their most recent treatment

Public study contact (from the registry)

Sr Director, Clinical Operations

1-877-774-GNPX

kcombs@genprex.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

10 listed

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FAQ about this NCT record

Is NCT04486833 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04486833?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04486833?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary