Study of Tislelizumab for Locally Advanced Non-Small Cell Lung Cancer Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy
NCT05468242 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2024-10-30
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
- DRUG
-
Neoadjuvant chemo-immunotherapy
The neoadjuvant chemo-immunotherapy before radiotherapy comprised of chemotherapy plus Tislelizumab \[200 mg, once every 3 weeks (Q3W)\].
- DRUG
-
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.
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Hui Liu · Sun Yat-sen University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-01
- Primary Completion
- 2024-12-30
- Completion
- 2024-12-30
Countries
- China
Study Locations
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