NCT06690671

A Single-Arm, Phase Ⅰb Study of Golidocitinib Combined With Anti-PD-1 for the Treatment of Previously Treated NSCLC

An Open-Label, Single-Arm, Phase Ib Exploratory Study to Evaluate the Safety and Efficacy of Golidocitinib in Combination With Anti-PD-1 in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated With First-Line Anti-PD-1 Containing Regimens

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase Ib, single-center, single-arm exploratory clinical study designed to evaluate the safety and efficacy of Golidocitinib in combination with anti-PD-1 monoclonal antibody in locally advanced or metastatic NSCLC treated with anti-PD-1 in combination with or without platinum-containing chemotherapy regimens.

Detailed description

This study is a phase Ib, single-center, single-arm exploratory clinical study designed to evaluate the safety and efficacy of Golidocitinib in combination with PD-1 monoclonal antibody in locally advanced or metastatic NSCLC treated with PD-1 monoclonal antibody in combination with or without platinum-containing chemotherapy regimens. The purpose of this part is to obtain the safety profile of the Golidocitinib in combination with PD-1 monoclonal antibody regimen in subjects with NSCLC who have failed treatment with first-line PD-1 monoclonal antibody in combination with or without platinum-containing chemotherapeutic regimens, and the recommended dose of the combination. The study will enroll 30 patients receiving Golidocitinib administered once daily (orally) at a starting dose of 75 mg up to a maximum dose of 150 mg; PD-1 monoclonal antibody at a clinically standardized dose (e.g., 200 mg IV Q3W), until the patients experienced disease progression, intolerable toxicity, or met the criteria for discontinuation of the trial drug. The primary endpoint was ORR, and secondary endpoints included PFS, DCR, OS, and safety. The study is expected to commence recruitment in mainland China in about Dec 2024. It is expected that the trial will end in July 2027.

Conditions

• Lung Cancer, Non-Small Cell

Interventions

Type	Name	Description
DRUG	Golidocitinib in combination with anti-PD-1	Golidocitinib 150/75 mg once daily (QD) with anti-PD-1 （200 mg IV Q3W），21 days in one cycle.

Timeline

• Start date: 2024-12-15
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2024-11-15
• Last updated: 2024-11-15

Locations

1 site across 1 country: China