Evaluating Efficacy and Safety of Anlotinib Combined With Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy for Locally Advanced Non-small Cell Lung Cancer
NCT05481775 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2022-11-21
Summary
This is a prospective, randomized, controlled phase II clinical study for evaluating anlotinib combined with concurrent chemoradiotherapy followed by consolidation immunotherapy versus concurrent chemoradiotherapy followed by consolidation immunotherapy in locally advanced, unresectable NSCLC.
Conditions
- Locally Advanced Non-small Cell Lung Cancer
- Efficacy and Safety
Interventions
- DRUG
-
Anlotinib 8mg qd po. Taking anlotinib daily for 2 weeks and stop for 1 week.
- DRUG
-
Docetaxel 25mg/m2 + Cisplatin 25mg/m2 QW
- RADIATION
-
Radiotherapy
Thoracic radiotherapy was delivered using the daily image-guided intensity modulated radiation therapy (IMRT) technique. The total radiation dose was 66-68 Gy to the gross tumor in 17-22 daily fractions.
- DRUG
-
Immunotherapy
consolidation Immunotherapy (Tislelizhu 200mg iv. drip, Q3W, up to 12 months.)
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Hui Liu, Professor · Sun yat-sen universtiy cancer center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-01
- Primary Completion
- 2025-04-01
- Completion
- 2025-09-30
Countries
- China
Study Locations
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