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Brief Title: Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients
Official 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)
Study ID: NCT05703971
Brief 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 will be conducted in 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: In Phase 1 dose selection, patients will be enrolled in sequential cohorts treated with successively higher doses of quaratusugene ozeplasmid in combination with atezolizumab. The recommended Phase 2 dose (RP2D) of quaratusugene ozeplasmid when given in combination with atezolizumab will be identified. Phase 2: Quaratusugene ozeplasmid in combination with atezolizumab will be further evaluated using the RP2D identified in Phase 1.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Rocky Mountain Cancer Centers, LLP, Lone Tree, Colorado, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, 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
Oncology_Hematology Care Clinical Trials, LLC, Fairfield, Ohio, United States
Willamette Valley Cancer Institute (Oregon), Eugene, Oregon, United States
Northwest Cancer Specialists, P.C., Portland, Oregon, United States
Providence Cancer Institute, Portland, Oregon, United States
Northwest Cancer Specialists, P.C., Portland, Oregon, United States
Northwest Cancer Specialists, P.C., Tigard, Oregon, United States
Texas Oncology - DFW, Dallas, Texas, United States
Texas Oncology - Northeast Texas, Tyler, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Name: Mark S Berger, MD
Affiliation: Genprex, Inc.
Role: STUDY_DIRECTOR