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

Inclusion Criteria:

• Male or female aged ≥18 years.

• Documented history of histologically or cytologically confirmed ES-SCLC, prior tostarting treatment with the combination of atezolizumab, carboplatin, and etoposide

• Complete Response (CR), Partial Response (PR), or Stable Disease (SD) afterreceiving 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 woundinfection, or comparable major residual complications of the surgery perInvestigator 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 relatedsymptoms for ≥7 days.

4. If had previous brain irradiation, post-treatment imaging must demonstratestability or regression of the brain metastases.

• Absolute neutrophil count (ANC) >1500/mm3, platelet count >100,000/mm3 within ≤28days.

• Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculatedcreatinine clearance >50 ml/min within ≤28 days.

• Adequate hepatic function as documented by serum bilirubin <1.5 mg/dL and aspartateaminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X upper limit ofnormal (ULN) within ≤28 days.

• Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤28days.

• 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 twoforms of contraception including one highly effective and one effective methodsbeginning ≥2 weeks prior to enrollment through for four months following the lastdose of study treatment.

• If male, must agree to no sperm donation during study treatment and for anadditional four months following the last dose of study treatment.

• Must have voluntarily signed an informed consent in accordance with institutionalpolicies.

Exclusion Criteria:

• Unable to tolerate atezolizumab treatment, leading to early treatmentdiscontinuation or prolonged/frequent dosage modifications in previous atezolizumabtreatment 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 notpermit 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 hepatitisinfection.

• Female who is pregnant or breastfeeding