Study on Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib for Advanced Lung Cancer Patients Who Progressed on Osimertinib

Sponsor: Genprex, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04486833

Provider View

This clinical trial is testing a new treatment that combines quaratusugene ozeplasmid (Reqorsa) with osimertinib to see if it is safe and effective for patients with advanced non-small cell lung cancer (NSCLC) who have specific EGFR mutations and whose cancer has worsened while on osimertinib.

Patient Parameters

Program Overview

The study aims to find out if adding quaratusugene ozeplasmid, a new gene therapy, to osimertinib can help control lung cancer in patients with specific genetic mutations. The trial will start with a Phase 1 to find the best dose, followed by Phase 2 to further test safety and effectiveness. In Phase 2, patients will either continue with the new combination treatment or switch to standard chemotherapy.

Description

This study, called Acclaim-1, is looking at a new treatment for advanced lung cancer that has spread or come back after treatment. It involves a new gene therapy called quaratusugene ozeplasmid (Reqorsa) combined with osimertinib, compared to standard chemotherapy. The study will be conducted in two phases:

  • Phase 1: This phase will determine the safest and most effective dose of the new treatment combination.
  • Phase 2a: Once the best dose is found, two groups of patients will receive the treatment to further assess its safety and how well it works.
  • Phase 2b: Patients will be randomly assigned to receive either the new treatment combination or standard chemotherapy to compare their effectiveness.

The study will monitor side effects and how well the treatment works in shrinking tumors. Patients may receive additional local treatments like radiation if needed before joining the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that is advanced or has come back and cannot be cured with surgery or radiation.
  • Have a specific EGFR mutation in the cancer cells.
  • Have previously responded to osimertinib for at least 4 months.
  • Have cancer that has worsened while on osimertinib and have measurable disease.
  • Be in good overall health with a performance status score of 0 or 1.
  • Be at least 28 days past major surgery and 10 days past minor surgery.
  • If there are brain metastases, they must be stable and not require steroids.
  • Be willing to provide a tumor sample for testing.
  • Have adequate blood cell counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Men must agree not to donate sperm during and after the study.
  • Must sign an informed consent form.

Exclusion Criteria

  • Cannot tolerate osimertinib treatment.
  • Have received chemotherapy or monoclonal antibodies recently.
  • Have had previous gene therapy.
  • Have other genetic mutations that can be treated with different targeted therapies.
  • Have had recent radiation to certain body areas.
  • Have active infections requiring treatment.
  • Have serious health conditions that would interfere with the study.
  • Have had a recent heart attack or unstable chest pain.
  • Have HIV or active hepatitis infection.
  • Are pregnant or breastfeeding.

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