RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe Reqorsa plus osimertinib is and how well it works. Reqorsa is a gene treatment for cancer. The study is for adults with advanced non-small cell lung cancer (NSCLC) that has an EGFR gene change and got worse while taking 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 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with confirmed NSCLC that is stage III or IV, or has come back and cannot be cured with surgery or radiation. A recent test must show an EGFR gene change.
  • Have had cancer improve or stay stable on osimertinib for at least 4 months, then worsen on scans. Osimertinib, alone or with other cancer drugs, must be your most recent treatment. Stop it for at least 10 days before joining.
  • Have cancer that can be measured on scans. Be fully active or able to do light work.
  • Be at least 28 days past major surgery, without serious wound problems. If cancer has spread to the brain without symptoms, it must be treated and stable or shrinking, with no seizures for 6 months, treatment finished at least 21 days ago, and no steroids for brain symptoms for at least 7 days.
  • Provide a past tumor sample or have a biopsy, a procedure to take a small tissue sample, during screening.
  • Have blood counts, kidney and liver tests, and heart function that meet the study's limits.
  • If able to become pregnant, have a negative blood pregnancy test within 7 days. If you or your female partner could become pregnant, use two required birth control methods from at least 2 weeks before joining until 4 months after the last dose. Men must not donate sperm during treatment or for 4 months after.
  • Choose to join and sign a consent form.

Who can't join

  • Cannot tolerate osimertinib, causing early stopping or long or frequent dose changes.
  • Have had gene therapy before, or have other gene changes that allow treatment with another approved targeted drug.
  • Had radiation to the skull, spine, chest, or pelvis within 30 days.
  • Have another active cancer that needs treatment throughout the body.
  • Have an active infection that needs treatment, known HIV infection, or active hepatitis, an infection of the liver.
  • Have a serious illness or other circumstances that the study doctor believes would prevent following study rules or attending follow-up visits.
  • Had a heart attack or unstable angina, a type of heart-related chest pain, within 6 months.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 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 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): 1. No history of seizures in the preceding six months. 2. Definitive treatment must be completed ≥21 days. 3. Must be off steroids administered because of brain metastases or related symptoms for ≥7 days. 4. Post-treatment imaging must demonstrate stability or regression of the brain metastases. 10. Must have and be willing to submit a prior tumor biopsy or undergo a biopsy during Screening to obtain tumor tissue for submission to a central laboratory for IHC analysis and FISH or qPCR testing. 11. Absolute neutrophil count (ANC) \>1500/mm3, platelet count \>100,000/mm3 within ≤28 days. 12. Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance \>50 ml/min within ≤28 days. 13. Adequate hepatic function as documented by serum bilirubin \<1.5 mg/dL and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X upper limit of normal (ULN) within ≤28 days. 14. Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤28 days. 15. If female of childbearing potential (FOCBP), must have negative serum pregnancy test (serum beta-human chorionic gonadotropin \[β-hCG\]) within ≤7 days. 16. FOCBP and non-sterile male patients with female partner(s) of childbearing potential must agree to use two forms of contraception including one highly effective and one effective method beginning ≥2 weeks prior to enrollment through four months following the last dose of study treatment. 17. If male, must agree to no sperm donation during study treatment and for an additional four months following the last dose of study treatment. 18. Must have voluntarily signed an informed consent in accordance with institutional policies. Exclusion Criteria: 1. Unable to tolerate osimertinib treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications as determined by the Investigator. 2. Received prior gene therapy. 3. Other genetic characteristics (such as ALK, ROS, BRAF V600E mutations) which make them a candidate for treatment with other approved targeted therapies. 4. Received radiotherapy to the skull, spine, thorax, or pelvis within ≤30 days. 5. Active concurrent malignancies, i.e., cancers other than NSCLC that require systemic therapy. 6. Active systemic viral, bacterial, or fungal infection(s) requiring treatment. 7. Serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the Investigator, would not permit adequate follow-up and compliance with the study protocol. 8. History of myocardial infarction or unstable angina within ≤6 months. 9. Known human immunodeficiency virus (HIV) infection or has active hepatitis infection. 10. Female who is pregnant or breastfeeding.

Study sites (10)

CA

CO

IL

KY

MD

NJ

OH

TX

VA