Pilot Study of DSP-0390 with Atezolizumab as Maintenance Therapy for Extensive Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of DSP-0390, an EBP inhibitor, combined with atezolizumab in patients with extensive stage small cell lung cancer ES-SCLC. This phase Ib pilot study focuses on patients whose disease has not worsened after initial treatment with platinum-based chemotherapy and anti-PD-L1 immunotherapy. The study aims to test whether blocking new cholesterol synthesis with DSP-0390 alongside atezolizumab is tolerable as maintenance therapy. Participants receive DSP-0390 orally each day in 21-day cycles, with dosing starting at 120 mg or 180 mg, or at a dose determined to be safe. Atezolizumab is given according to standard care, usually as an intravenous infusion every three weeks, but its dosing schedule is not dictated by the study. Treatment continues until the disease progresses or unacceptable side effects occur, for up to two years. Throughout the study, participants are monitored for treatment-related side effects until 30 days after finishing treatment. Researchers measure adverse events and tumor response using standard criteria. The study includes regular visits for assessments and safety monitoring over an estimated total duration of two years and 30 days, with follow-up extending to about two and a half years.

DSP-0390 in Combination With Atezolizumab for Small Cell Lung Cancer