Phase 1 Study of Golidocitinib with Tislelizumab and Chemotherapy as First Treatment for Advanced Non-small Cell Lung Cancer with PD-L1 1%

What this Trial Is About

Researchers are evaluating whether the combination of golidocitinib with tislelizumab and chemotherapy can improve progression-free survival in patients with advanced non-small cell lung cancer NSCLC who have a PD-L1 expression level of 1% or higher. This phase 1B clinical study focuses on patients newly diagnosed with locally advanced or metastatic NSCLC who cannot undergo surgery or radiotherapy. The study is sponsored by the Peking University Cancer Hospital & Institute and aims to understand the efficacy and safety of this combination as a first-line treatment. Participants will first receive two cycles of tislelizumab and chemotherapy, followed by two cycles of tislelizumab combined with golidocitinib taken orally daily for six weeks. After completing these five cycles, patients will continue treatment with tislelizumab and chemotherapy until they either cannot tolerate it or their disease progresses. Chemotherapy drugs used may include pemetrexed, cisplatin, carboplatin, paclitaxel, or albumin paclitaxel, delivered via intravenous infusion, while tislelizumab is given intravenously every three weeks. During the study, participants will be closely monitored with assessments including measurable tumor lesions and organ function tests. The main outcome measured is progression-free survival up to about 24 months. Secondary outcomes include response rates, duration and timing of responses, overall survival up to 60 months, and adverse events over approximately two years. Participants will be followed regularly throughout the treatment and evaluation periods to track these outcomes and ensure safety.

A Study on the Efficacy and Safety of Golidocitinib Combined With Tislelizumab and Chemotherapy as First-line Treatment for Advanced NSCLC