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

RecruitingPhase 1/2

A Phase 1/2 Clinical Trial of Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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):

  1. No history of seizures in the preceding six months.
  2. Definitive treatment must be completed ≥21 days prior to enrollment.
  3. Must be off steroids administered because of brain metastases or related symptoms for ≥7 days.
  4. 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.

Exclusion Criteria:

* 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

About the study

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).

What is being tested

Sponsor: Genprex, Inc. · Participants: 62 · Started: May 9, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05703971

Locations in the U.S.

ColoradoRocky Mountain Cancer Centers, LLP, Lone Tree
MissouriWashington University School of Medicine - Siteman Cancer Center, St Louis
OhioGabrail Cancer Center Research, Canton
Oncology_Hematology Care Clinical Trials, LLC, Cincinnati
Oncology_Hematology Care Clinical Trials, LLC, Cincinnati
Oncology_Hematology Care Clinical Trials, LLC, Cincinnati
Oncology_Hematology Care Clinical Trials, LLC, Cincinnati
Oncology_Hematology Care Clinical Trials, LLC, Fairfield
OregonWillamette Valley Cancer Institute (Oregon), Eugene
Northwest Cancer Specialists, P.C., Portland
Northwest Cancer Specialists, P.C., Portland
Providence Cancer Institute, Portland
Northwest Cancer Specialists, P.C., Tigard
TexasTexas Oncology - DFW, Dallas
Texas Oncology - Northeast Texas, Tyler
VirginiaVirginia Cancer Specialists, PC, Fairfax

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.