Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients
Start Date
5/9/2024
Completion Date
8/1/2027
Summary
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).
Detailed Description
Acclaim-3 is an open-label, multi-center, Phase 1/2 study evaluating the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with ES-SCLC who did not develop tumor progression after receiving at least 3 cycles, and no more than 4 cycles, of induction therapy with carboplatin plus etoposide and atezolizumab. Toxicities will be assessed by the Investigator using United States National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Serious Adverse Events and Dose Limiting Toxicities (DLTs) will be reviewed by a safety review committee. Phase 1: Enrollment in Phase 1 is complete and the recommended Phase 2 dose (RP2D) of quaratusugene ozeplasmid when given in combination with atezolizumab was determined. Phase 2: Enrollment has been initiated and enrolled patients are treated with quaratusugene ozeplasmid at the RP2D in combination with atezolizumab.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
quaratusugene ozeplasmid
atezolizumab
Conditions
Locations
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado 80124
United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri 63110
United States
Gabrail Cancer Center Research
Canton, Ohio 44718
United States
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio 45211
United States
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio 45236
United States
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio 45242
United States
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio 45245
United States
Oncology_Hematology Care Clinical Trials, LLC
Fairfield, Ohio 45014
United States
Willamette Valley Cancer Institute (Oregon)
Eugene, Oregon 97401
United States
Northwest Cancer Specialists, P.C.
Portland, Oregon 97213-2982
United States
Providence Cancer Institute
Portland, Oregon 97213
United States
Northwest Cancer Specialists, P.C.
Portland, Oregon 97227
United States
Northwest Cancer Specialists, P.C.
Tigard, Oregon 97223
United States
Texas Oncology - DFW
Dallas, Texas 75246
United States
Texas Oncology - Northeast Texas
Tyler, Texas 75702
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington 98684
United States