RecruitingPhase 1 / Phase 2

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

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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests quaratusugene ozeplasmid (Reqorsa) with atezolizumab for adults with small cell lung cancer that has spread widely. It is for people whose cancer shrank, disappeared, or stayed stable after their first treatment. The study will choose a dose, then test its safety and how well it works as ongoing treatment.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, with small cell lung cancer that has spread widely and was confirmed by tissue or cell testing.
  • Have cancer that shrank, disappeared, or stayed stable after 3 or 4 cycles of atezolizumab, carboplatin, and etoposide.
  • Be fully active or able to do light work despite some limits on hard physical activity.
  • Have had any major surgery at least 28 days ago, with no open wound, wound infection, or other major lasting problems.
  • If cancer has spread to the brain, have no symptoms or seizures in the past 6 months. Brain treatment must be finished at least 21 days before joining, and steroids for brain symptoms stopped for at least 7 days. After brain radiation, scans must show the cancer is stable or shrinking.
  • Meet the study’s blood cell, kidney, liver, and heart test requirements, with tests done within 28 days.
  • If able to become pregnant, have a negative blood pregnancy test within 7 days before treatment. People covered by the birth control rules must use two methods from at least 2 weeks before joining until 4 months after the last dose. Men must not donate sperm during treatment or for 4 months afterward.
  • Choose to join and sign a consent form.

Who can't join

  • Could not tolerate earlier atezolizumab treatment, causing it to stop early or need long or frequent dose changes.
  • Have had gene therapy.
  • Have had radiation to the brain to prevent cancer spread, or added chest radiation after initial treatment.
  • Have an active viral, bacterial, or fungal infection affecting the body that needs treatment, known HIV infection, or active hepatitis infection.
  • Have a serious illness or other circumstances that would prevent follow-up visits or following study rules.
  • Have a history of an autoimmune disease—when the immune system attacks the body—that required treatment to weaken the immune system.
  • Have had a heart attack or unstable angina—new or worsening chest pain—in the past 6 months.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (17)

CO

MO

OH

OR

TX

VA

WA