NCT05703971 Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients
| NCT ID | NCT05703971 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Genprex, Inc. |
| Condition | Small Cell Lung Cancer Extensive Stage |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2024-05-09 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 62 participants in total. It began in 2024-05-09 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Mark S Berger, MD
STUDY DIRECTOR
Genprex, Inc.
Frequently Asked Questions
Who can join the NCT05703971 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small Cell Lung Cancer Extensive Stage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05703971 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05703971 currently recruiting?
Yes, NCT05703971 is actively recruiting participants. Contact the research team at kcombs@genprex.com for enrollment information.
Where is the NCT05703971 trial being conducted?
This trial is being conducted at Lone Tree, United States, St Louis, United States, Canton, United States, Cincinnati, United States and 11 additional locations.
Who is sponsoring the NCT05703971 clinical trial?
NCT05703971 is sponsored by Genprex, Inc.. The principal investigator is Mark S Berger, MD at Genprex, Inc.. The trial plans to enroll 62 participants.
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