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Spots Global Cancer Trial Database for Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Mark S Berger, MD

Affiliation: Genprex, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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