Small Cell Lung Cancer Extensive Stage Clinical Trial
— Acclaim-3Official title:
A Phase 1/2 Clinical Trial of Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
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 will be conducted in 2 phases, a dose selection phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2).
Status | Recruiting |
Enrollment | 62 |
Est. completion date | August 2027 |
Est. primary completion date | February 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 [ß-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. |
Country | Name | City | State |
---|---|---|---|
United States | Oncology_Hematology Care Clinical Trials, LLC | Cincinnati | Ohio |
United States | Oncology_Hematology Care Clinical Trials, LLC | Cincinnati | Ohio |
United States | Oncology_Hematology Care Clinical Trials, LLC | Cincinnati | Ohio |
United States | Oncology_Hematology Care Clinical Trials, LLC | Cincinnati | Ohio |
United States | Texas Oncology - DFW | Dallas | Texas |
United States | Willamette Valley Cancer Institute (Oregon) | Eugene | Oregon |
United States | Virginia Cancer Specialists, PC | Fairfax | Virginia |
United States | Oncology_Hematology Care Clinical Trials, LLC | Fairfield | Ohio |
United States | Rocky Mountain Cancer Centers, LLP | Lone Tree | Colorado |
United States | Northwest Cancer Specialists, P.C. | Portland | Oregon |
United States | Northwest Cancer Specialists, P.C. | Portland | Oregon |
United States | Providence Cancer Institute | Portland | Oregon |
United States | Washington University School of Medicine - Siteman Cancer Center | Saint Louis | Missouri |
United States | Northwest Cancer Specialists, P.C. | Tigard | Oregon |
United States | Texas Oncology - Northeast Texas | Tyler | Texas |
United States | Northwest Cancer Specialists, P.C. | Vancouver | Washington |
Lead Sponsor | Collaborator |
---|---|
Genprex, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) - Phase 1 | The MTD and/or RP2D of the combination of quaratusugene ozeplasmid and atezolizumab.
Note: if a MTD is not determined, the RP2D will be selected based on all available data (safety, PK, PD, and preliminary efficacy). |
First 21-days at each dose level | |
Primary | Progression-Free Survival Rate (PFSR) - Phase 2 | PFSR at 18 weeks according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). | 18-weeks from Day 1 of maintenance therapy | |
Secondary | Safety Profile - Phase 1 | Adverse events according to CTCAE v5.0 | Approximately 6 months | |
Secondary | Progression-free Survival (PFS) - Phase 1 & Phase 2 | PFS per RECIST 1.1. PFS is defined as time from Day 1 of maintenance therapy to disease progression or death. | Approximately 5 months | |
Secondary | Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1 & Phase 2 | Concentration of quaratusugene ozeplasmid in whole blood samples. | First 21-day treatment cycle | |
Secondary | Overall Survival (OS) - Phase 1 & Phase 2 | Number of months from Day 1 of maintenance therapy to the date of death. | Approximately 18 months |
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