NCT05192681

Tislelizumab as Cross-line Treatment for Advanced NSCLC

Tislelizumab Combined With Docetaxel for Cross-line Treatment of First-line Resistant Advanced NSCLC，a Phase II Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	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 date: 2021-10-10
• Primary completion: 2023-10-10
• Completion: 2023-10-10
• First posted: 2022-01-14
• Last updated: 2022-01-14

Locations

1 site across 1 country: China