Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients (Acclaim-3)
Small Cell Lung Cancer Extensive Stage
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer Extensive Stage focused on measuring atezolizumab, Tumor Suppressor Gene 2 (TUSC2), Lipid Nanoparticle (LNP), Gene Therapy, TECENTRIQ, ES-SCLC, Reqorsa, quaratusugene ozeplasmid
Eligibility Criteria
Inclusion Criteria: 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 3 cycles, and no more than 4 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 be ≥10 days beyond minor surgical procedures such as biopsy of subcutaneous tumors, pleuroscopy, etc., 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): a. No history of seizures in the preceding 6 months; b. Definitive treatment must be completed ≥21 days prior to enrollment; c. Must be off steroids administered because of brain metastases or related symptoms for ≥7 days; d. 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 ≤21 days. Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance >50 ml/min within ≤21 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 ≤21 days. Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤21 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 men who are sexually active with FOCBP must agree to use 2 forms of contraception during the study period and for 4 months following the last dose of study treatment. If male, must agree to no sperm donation during study treatment and for an additional 4 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase 1
Phase 2
Up to 2 sequential dose selection cohorts will be treated with quaratusugene ozeplasmid (intravenous (IV) administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) until disease progression or unacceptable toxicity. Quaratusugene ozeplasmid doses will be evaluated (0.09 [starting dose], and 0.12 mg/kg) until the RP2D is identified.
Patients will be treated with the RP2D of quaratusugene ozeplasmid (IV administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) until disease progression or unacceptable toxicity