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.
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).