RecruitingPhase 2NCT05468242

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


Sponsor

Sun Yat-sen University

Enrollment

116 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the immunotherapy drug tislelizumab in combination with other treatments for people with locally advanced non-small cell lung cancer that cannot be surgically removed. **You may be eligible if...** - You have been diagnosed with locally advanced non-small cell lung cancer (stage III) that cannot be surgically removed - You have not previously received chemotherapy or radiation for this cancer - Your cancer can be measured on imaging scans - You are in reasonably good overall health (able to carry out daily activities) **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body (stage IV) - You have a serious autoimmune disease - You have previously received immunotherapy - You have significant lung disease or have had major lung surgery - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant chemo-immunotherapy

The neoadjuvant chemo-immunotherapy before radiotherapy comprised of chemotherapy plus Tislelizumab \[200 mg, once every 3 weeks (Q3W)\].

DRUGBevacizumab

The Bevacizumab was administrated concurrently with neoadjuvant chemo-immunotherapy (7.5mg/kg) once every 3 weeks (Q3W).

RADIATIONRadiotherapy

Definitive radiotherapy to the thoracic lesions.

DRUGTislelizumab

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.


Locations(1)

Sun Yat-sen University

Guangzhou, China

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NCT05468242


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