Phase 2 Study of Golidocitinib and PD-1 Inhibitors as Maintenance Therapy for Untreated Extensive-Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of golidocitinib combined with PD-1 inhibitors as a maintenance treatment for patients with previously untreated extensive-stage small cell lung cancer ES-SCLC. This is an open-label, single-arm phase 2 study that aims to determine the recommended dose and preliminary efficacy of this combination treatment in this patient population. The study has two parts Part A explores the safety and dose tolerance of golidocitinib with PD-1 inhibitors, while Part B assesses the preliminary effectiveness and safety of the selected dose. Participants first receive 4 cycles of PD-1 inhibitors combined with chemotherapy during an induction phase. Those without disease progression then continue with maintenance treatment using the combination of golidocitinib and PD-1 inhibitors. Treatment may continue until disease progression, unacceptable side effects, death, withdrawal of consent, or completion of 24 months. Participants will undergo screening assessments to confirm eligibility before starting treatment. During the study, researchers will monitor progression-free survival over a 2-year period as the primary outcome. Other measures include overall survival and safety assessments. Participants will have regular evaluations including laboratory tests, imaging scans, and clinical examinations to track treatment effects and side effects throughout the study duration.

Golidocitinib With PD-1 Inhibitors as Maintenance Treatment for Previously Untreated ES-SCLC