Small Cell Lung Cancer Extensive Stage study: Quaratusugene ozeplasmid vs Atezolizumab
Official title Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients
ClinicalTrials.gov ID: NCT05703971
What this study is testing
What is Quaratusugene ozeplasmid?
An investigational nonviral immunogene therapy being studied for maintenance treatment of extensive stage small cell lung cancer. It is designed to interrupt cancer cell signaling pathways, promote cancer cell death, and modulate the immune response.
Also referred to as REQORSA.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if the combination is safe and may help patients after initial treatment.
- Who it's for
- It is looking for adults who have extensive‑stage small cell lung cancer and have finished their first round of therapy.
- What's involved
- Participants will receive the new drug and atezolizumab, have regular clinic visits, and undergo blood and imaging tests to monitor safety and response.
- Time commitment
- The study lasts about 12 months, with visits every few weeks for treatment and monitoring.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after receiving at least three cycles, and no more than four cycles, of...
- 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...
You likely can't join if
- Unable to tolerate atezolizumab treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications in previous...
- 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...
- History of autoimmune disease requiring immunosuppression.
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Lone Tree, Colorado, United States
- St Louis, Missouri, United States
- Canton, Ohio, United States
- Cincinnati, Ohio, United States
- Fairfield, Ohio, United States
- Eugene, Oregon, United States
- Portland, Oregon, United States
- Tigard, Oregon, United States
- Dallas, Texas, United States
- Tyler, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Lone Tree, Colorado, United States; St Louis, Missouri, United States; Canton, Ohio, United States; Cincinnati, Ohio, United States; Fairfield, Ohio, United States; Eugene, Oregon, United States and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.