Actively Recruiting
Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients
Led by Genprex, Inc. · Updated on 2025-10-16
62
Participants Needed
17
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer before starting induction therapy with atezolizumab, carboplatin, and etoposide
- Complete Response, Partial Response, or Stable Disease after 3 to 4 cycles of atezolizumab, carboplatin, and etoposide
- Eastern Cooperative Oncology Group performance status score of 0 or 1
- At least 28 days since major surgery with no active wound infection or complications
- Asymptomatic brain metastases meeting all: no seizures in past 6 months; treatment completed at least 21 days before enrollment; off steroids for at least 7 days; stable or regressing brain lesions if previously irradiated
- Absolute neutrophil count greater than 1500/mm3 and platelet count greater than 100,000/mm3 within 28 days
- Adequate kidney function with serum creatinine ≤1.5 mg/dL or creatinine clearance >50 ml/min within 28 days
- Adequate liver function with bilirubin <1.5 mg/dL and AST and ALT ≤2.5 times upper limit of normal within 28 days
- Stable heart function with left ventricular ejection fraction ≥40% within 28 days
- For females of childbearing potential, negative pregnancy test within 7 days before first dose
- Agreement to use two forms of contraception for females of childbearing potential and sexually active non-sterile males from 2 weeks before enrollment through 4 months after last dose
- Male participants must agree to no sperm donation during treatment and for 4 months after last dose
- Signed informed consent
You will not qualify if you...
- Unable to tolerate atezolizumab previously, causing early discontinuation or frequent dose changes
- Prior gene therapy
- Received prophylactic cranial irradiation or consolidation thoracic radiation
- Active systemic viral, bacterial, or fungal infection requiring treatment
- Serious illness or conditions preventing follow-up or compliance
- History of autoimmune disease requiring immunosuppression
- Myocardial infarction or unstable angina within 6 months
- Known HIV infection or active hepatitis
- Female who is pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 17 locations
1
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States, 80124
Actively Recruiting
2
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States, 63110
Actively Recruiting
3
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Actively Recruiting
4
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States, 45211
Actively Recruiting
5
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States, 45236
Actively Recruiting
6
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States, 45242
Actively Recruiting
7
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States, 45245
Actively Recruiting
8
Oncology_Hematology Care Clinical Trials, LLC
Fairfield, Ohio, United States, 45014
Actively Recruiting
9
Willamette Valley Cancer Institute (Oregon)
Eugene, Oregon, United States, 97401
Actively Recruiting
10
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97213-2982
Actively Recruiting
11
Providence Cancer Institute
Portland, Oregon, United States, 97213
Actively Recruiting
12
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97227
Actively Recruiting
13
Northwest Cancer Specialists, P.C.
Tigard, Oregon, United States, 97223
Actively Recruiting
14
Texas Oncology - DFW
Dallas, Texas, United States, 75246
Actively Recruiting
15
Texas Oncology - Northeast Texas
Tyler, Texas, United States, 75702
Actively Recruiting
16
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
17
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States, 98684
Terminated
Research Team
S
Sr Director, Clinical Operations
CONTACT
C
Chief Medical Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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