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Quaratusugene Ozeplasmid and Atezolizumab for ES-SCLC

This study is testing a combination of two treatments, quaratusugene ozeplasmid and atezolizumab, for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC). These patients have already received initial chemotherapy and atezolizumab and their cancer has not worsened. Quaratusugene ozeplasmid is an experimental treatment that aims to stop cancer cell growth and encourage cancer cell death. Atezolizumab is a drug that helps your immune system fight cancer. The study is looking to find the best dose of quaratusugene ozeplasmid and see how well this combination prevents the cancer from growing. Enrollment for the second phase of this study has started.

Study design
This is an open-label, multi-center study with two phases, enrolling about 62 participants. The first phase, which determined the dose, is complete, and the second phase is now evaluating safety and effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures how long participants live without their cancer getting worse at 18 weeks from the start of maintenance therapy.

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

NCT05703971

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Genprex, Inc.
~62 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:quaratusugene ozeplasmidatezolizumab

At a glance

Recruiting sites
16 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) - Phase 1
Measured over First 21-days at each dose level
+1 more outcome measured

Conditions

Small Cell Lung Cancer Extensive Stage

Explore related trials

Lung Small Cell Carcinoma

Where it's being run

17 sites across 7 states
Ohio6
Oregon5
Texas2
Colorado1
Missouri1
Virginia1
Washington1

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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Eligibility criteria

Inclusion

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):
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

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

What this trial measures

  • Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) - Phase 1First 21-days at each dose level

    The MTD and/or RP2D of the combination of quaratusugene ozeplasmid and atezolizumab. Note: if a MTD is not determined, the RP2D will be selected based on all available data (safety, PK, PD, and preliminary efficacy).

  • Progression-Free Survival Rate (PFSR) - Phase 218-weeks from Day 1 of maintenance therapy

    PFSR at 18 weeks according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).