drugset / Trial / NCT05192681

Tislelizumab as Cross-line Treatment for Advanced NSCLC

NCT05192681 ↗

Phase 2 Unknown 35 enrolled Fujian Cancer Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study is a single-arm, prospective, open phase II clinical study, exploring the efficacy and safety for advanced non-small cell lung cancer after progression of first-line Tislelizumab combined with chemotherapy and continuing Tislelizumab in combination with docetaxel. The primary study endpoint of this study is measured by progression-free survival (PFS). 1. Tislelizumab: The recommended dose is 200 mg/dose administered every three weeks on the first day of each cycle. 2. Docetaxel: 60-75 mg/m2 every 3 weeks, administered on day 1 of each cycle. 3. Treatment cycle: Tislelizumab in combination with docetaxel until the development of PD, unacceptable toxicities, withdrawal of informed consent, end of study, lost to follow-up, or death, whichever occurs first.

Timeline

Start
2021-10-10
Primary completion
2023-10-10
Completion
2023-10-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous
Background Docetaxel Small molecule 60 mg/m2 —
Background Docetaxel Small molecule 75 mg/m2 —