NCT06540950

Efficacy and Safety of Concurrent Chemoradiotherapy With Oral Vinorelbine in Patients With Non-small Cell Lung Cancer

Study of Oral Vinorelbine Single Drug Concurrent Chemoradiotherapy and Immune-maintenance Therapy in Patients With Unresectable Stage III Non-small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of concurrent chemoradiotherapy with oral vinorelbine, and immune maintenance therapy in patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy, with a view to providing an effective treatment regimen for these patients.

Detailed description

Patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy are enrolled to receive concurrent chemoradiotherapy with oral vinorelbine, and immune-maintenance therapy. The primary endpoint is objective response rate, and secondary endpoints include disease control rate, progression-free survival, compliance and safety.

Conditions

• Vinorelbine

Interventions

Type	Name	Description
DRUG	vinorelbine	Vinorelbine is administered orally at 60mg per square meter per week by body surface area before radiotherapy and continued to be administered at 30mg per square meter per week during radiotherapy until the end of radiotherapy. Within 6 weeks after the end of radiotherapy, there are no serious side effects, and immune checkpoint inhibitors monotherapy can be performed.

Timeline

• Start date: 2023-03-20
• Primary completion: 2025-04-10
• Completion: 2026-06-10
• First posted: 2024-08-07
• Last updated: 2024-08-07

Locations

1 site across 1 country: China