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Reqorsa and Osimertinib for Advanced Lung Cancer

This study is testing a new combination treatment for advanced non-small cell lung cancer (NSCLC) that has specific changes in the EGFR gene and has gotten worse after treatment with osimertinib. The study combines quaratusugene ozeplasmid (Reqorsa), an experimental gene therapy designed to target cancer cells and boost the immune system, with osimertinib, a standard oral medication for this type of lung cancer. The goal is to see how safe and effective this combination is. You might be able to join if you are 18 or older, have advanced NSCLC with EGFR mutations, and your cancer has progressed on osimertinib. The study is currently in Phase 2a, meaning it's evaluating the safety and preliminary effectiveness of the combination.

Study design
This is an open-label, multi-center, Phase 1/2 study. Participants in Phase 2b will be randomly assigned to receive either the investigational combination or platinum-based chemotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long patients live without their cancer getting worse (progression-free survival) at approximately 11 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04486833

Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib

Recruiting
PHASE1Ages 18+InterventionalTreatment
Genprex, Inc.
~158 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:quaratusugene ozeplasmidosimertinibPlatinum-Based Chemotherapy

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended Phase 2 Dose (RP2D) - Phase 1
Measured over First 21-day treatment cycle for each dose level cohort
+2 more outcomes measured

Conditions

Carcinoma, Non-Small Cell Lung

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Where it's being run

10 sites across 9 states
Virginia2
California1
Colorado1
Illinois1
Kentucky1
Maryland1
New Jersey1
Ohio1

Study leadership

  • Mark S. Berger, MD · STUDY_DIRECTOR · Genprex, Inc.

Who to contact

Sr Director, Clinical Operations
[email protected]
1-877-774-GNPX
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients may have had treatment with other EGFR inhibitors as single agents prior to osimertinib.
Patients may have progression on osimertinib treatment being used for adjuvant therapy after surgery. 7. Eastern Cooperative Oncology Group performance status (ECOG PS) score from 0 to 1. 8. Must be ≥28 days beyond major surgical procedures such as thoracotomy, laparotomy, or joint replacement and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery per Investigator assessment. 9. Asymptomatic brain metastases must meet ALL criteria of the following (a-d):

What this trial measures

  • Recommended Phase 2 Dose (RP2D) - Phase 1First 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 2aApproximately 3 months

    ORR (complete response \[CR\]+ partial response \[PR\]) according to RECIST using best overall response.

  • Progression-free Survival (PFS) - Phase 2bApproximately 11 months

    PFS from randomization to disease progression or death. Response according to RECIST.