Trials / Withdrawn
WithdrawnNCT05481775
Evaluating Efficacy and Safety of Anlotinib Combined With Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy for Locally Advanced Non-small Cell Lung Cancer
Evaluating Anlotinib Combined With Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy Versus Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy for Locally Advanced Non-small Cell Lung Cancer: A Prospective, Randomized Controlled Phase II Clinical Trial
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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. In this study, the enrolled patients were divided into the experimental group and the control group at a ratio of 1:1. The patients in the experimental group received anlotinib combined with curative concurrent chemoradiotherapy first, while the patients in the control group received curative concurrent chemoradiotherapy. Those who are evaluated as CR, PR or SD after the aforementioned treatment will enter consolidation immunotherapy. Patients will receive tislelizumab 200mg iv. drip, Q3W, for up to 12 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anlotinib | Anlotinib 8mg qd po. Taking anlotinib daily for 2 weeks and stop for 1 week. |
| DRUG | Chemotherapy | 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.) |
Timeline
- Start date
- 2022-04-01
- Primary completion
- 2025-04-01
- Completion
- 2025-09-30
- First posted
- 2022-08-01
- Last updated
- 2022-11-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05481775. Inclusion in this directory is not an endorsement.