NCT07110103

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

Golidocitinib With PD-1 Inhibitors as Maintenance Treatment in Patients With Previously Untreated Extensive-stage Small Cell Lung Cancer: an Open-label, Single-arm, Phase 2 Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, phase 2 study to evaluate the safety and efficacy of golidocitinib with PD-1 inhibitors as maintenance treatment in patients with previously untreated extensive-stage small cell lung cancer.

Detailed description

This study is a single-arm clinical study to evaluate the safety and efficacy of golidocitinib combined with PD-1 inhibitors in ES-SCLC. The study consists of two parts: Part A (dose escalation), which will include previously untreated ES-SCLC subjects, aims to explore the safety and tolerability of golidocitinib combined with PD-1 inhibitors in this population and determine the recommended dose of the combination. Part B (dose expansion), which will include previously untreated ES-SCLC subjects, aims to explore the preliminary efficacy of golidocitinib combined with PD-1 inhibitors in this population and evaluate the efficacy and safety. After completing the required assessments during the screening period and meeting the eligibility criteria, the subjects will first receive 4 cycles of PD-1 inhibitor combined with chemotherapy in the induction phase, followed by maintenance treatment with PD-1 inhibitor combined with golidocitinib. Subjects will continue to receive PD-1 inhibitor combined with golidocitinib until disease progression, intolerable toxicity, death, withdrawal of informed consent by the subject, or 24 months of treatment.

Conditions

• SCLC
• SCLC, Extensive Stage

Interventions

Type	Name	Description
DRUG	golidocitinib with PD-1 inhibitors	Dose escalation: 75/150mg golidocitinib with PD-1 inhibitors as maintenance treatment after 4 cycles of PD-1 inhibitors and chemotherapy. Dose expansion: Selected dose (75mg or 150mg) of golidocitinib with PD-1 inhibitors as maintenance treatment after 4 cycles of PD-1 inhibitors and chemotherapy.

Timeline

• Start date: 2025-10-31
• Primary completion: 2027-03-31
• Completion: 2028-06-30
• First posted: 2025-08-07
• Last updated: 2026-02-27

Locations

2 sites across 1 country: China