Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients

Recruiting now · Phase 1/Phase 2

Conditions studied: Small Cell Lung Cancer Extensive Stage

In brief

This clinical trial will evaluate the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC). The study is comprised of 2 phases, a dose selection phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2).

Key facts

Study ID

NCT05703971

Run by

Genprex, Inc.

People needed

62

Starts

2024-05-09

Expected to finish

2027-08-01

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged ≥18 years.
• Documented history of histologically or cytologically confirmed ES-SCLC, prior to starting treatment with the combination of atezolizumab, carboplatin, and etoposide
• Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after receiving at least three cycles, and no more than four cycles, of atezolizumab, carboplatin, and etoposide.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score from 0 to 1.
• 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.
• Asymptomatic brain metastases must meet ALL criteria of the following (a-d):
• No history of seizures in the preceding six months.
• Definitive treatment must be completed ≥21 days prior to enrollment.
• Must be off steroids administered because of brain metastases or related symptoms for ≥7 days.
• If had previous brain irradiation, post-treatment imaging must demonstrate stability or regression of the brain metastases.
• Absolute neutrophil count (ANC) >1500/mm3, platelet count >100,000/mm3 within ≤28 days.
• Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance >50 ml/min within ≤28 days.
• 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.
• Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤28 days.
• If female of childbearing potential (FOCBP), must have negative serum pregnancy test (serum beta-human chorionic gonadotropin [β-hCG]) within ≤7 days of first dose.
• FOCBP and non-sterile men who are sexually active with FOCBP must agree to use two forms of contraception including one highly effective and one effective methods beginning ≥2 weeks prior to enrollment through for four months following the last dose of study treatment.
• If male, must agree to no sperm donation during study treatment and for an additional four months following the last dose of study treatment.
• Must have voluntarily signed an informed consent in accordance with institutional policies.

You may not qualify if…

• Unable to tolerate atezolizumab treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications in previous atezolizumab treatment as determined by the Investigator.
• Received prior gene therapy.
• Received prophylactic cranial irradiation or consolidation thoracic radiation.
• Active systemic viral, bacterial, or fungal infection(s) requiring treatment.
• 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.
• History of autoimmune disease requiring immunosuppression.
• History of myocardial infarction or unstable angina within ≤6 months.
• Known human immunodeficiency virus (HIV) infection or has active hepatitis infection.
• Female who is pregnant or breastfeeding

Where it is running

• Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado, United States (enrolling)
• Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri, United States (enrolling)
• Gabrail Cancer Center Research — Canton, Ohio, United States (enrolling)
• Oncology_Hematology Care Clinical Trials, LLC — Cincinnati, Ohio, United States (enrolling)
• Oncology_Hematology Care Clinical Trials, LLC — Cincinnati, Ohio, United States (enrolling)
• Oncology_Hematology Care Clinical Trials, LLC — Cincinnati, Ohio, United States (enrolling)
• Oncology_Hematology Care Clinical Trials, LLC — Cincinnati, Ohio, United States (enrolling)
• Oncology_Hematology Care Clinical Trials, LLC — Fairfield, Ohio, United States (enrolling)
• Willamette Valley Cancer Institute (Oregon) — Eugene, Oregon, United States (enrolling)
• Northwest Cancer Specialists, P.C. — Portland, Oregon, United States (enrolling)
• Providence Cancer Institute — Portland, Oregon, United States (enrolling)
• Northwest Cancer Specialists, P.C. — Portland, Oregon, United States (enrolling)
• Northwest Cancer Specialists, P.C. — Tigard, Oregon, United States (enrolling)
• Texas Oncology - DFW — Dallas, Texas, United States (enrolling)
• Texas Oncology - Northeast Texas — Tyler, Texas, United States (enrolling)
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States (enrolling)
• Northwest Cancer Specialists, P.C. — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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