NCT05468242

Study of Tislelizumab for Locally Advanced Non-Small Cell Lung Cancer Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy

A Phase II Trial of Tislelizumab as Consolidation Therapy in Patients With Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The phase II Study is to explore the efficacy and safety of Tislelizumab as consolidation therapy in patients with locally advanced non-small cell lung cancer who have not progressed following neoadjuvant chemotherapy plus Tislelizumab ± Bevacizumab and definitive concurrent chemoradiation therapy.

Conditions

• Stage III Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Neoadjuvant chemo-immunotherapy	The neoadjuvant chemo-immunotherapy before radiotherapy comprised of chemotherapy plus Tislelizumab \[200 mg, once every 3 weeks (Q3W)\].
DRUG	Bevacizumab	The Bevacizumab was administrated concurrently with neoadjuvant chemo-immunotherapy (7.5mg/kg) once every 3 weeks (Q3W).
RADIATION	Radiotherapy	Definitive radiotherapy to the thoracic lesions.
DRUG	Tislelizumab	Tislelizumab consolidation (200 mg) is performed once every 3 weeks after the neoadjuvant therapy and concurrent chemo-radiotherapy, and will continue on a Q3W schedule for a maximum duration of 12 months.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2022-07-21
• Last updated: 2024-10-30

Locations

1 site across 1 country: China