NCT06260553

Metronomic Oral Vinorelbine Combination With Tislelizumab in EGFR/ALK-negative Advanced NSCLC

Metronomic Oral Vinorelbine Combination With Tislelizumab in EGFR/ALK-negative Advanced NSCLC Patients Intolerant to First-line Standard Chemotherapy: A Singlearm Phase Il Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in EGFR/ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy.

Detailed description

This study is a clinical intervention study. The patients who comfirm the criteria will be treated with tislelizumab plus metronomic oral vinorelbine. The patients will be followed up until the tumor progressed, and the efficacy (PFS, ORR, DCR) of tumor therapy were evaluated. Drug administration regimen: tislelizumab 200mg intravenous drip once every 3 week3; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.

Conditions

• EGFR/ ALK-negative Advanced NSCLC

Interventions

Type	Name	Description
DRUG	tislelizumab and metronomic oral vinorelbine	tislelizumab 200mg intravenous drip once every three weeks; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.

Timeline

• Start date: 2024-02-07
• Primary completion: 2025-02-07
• Completion: 2025-08-07
• First posted: 2024-02-15
• Last updated: 2024-02-15

Locations

1 site across 1 country: China