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Recruiting Phase 2 NCT05468242

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

Trial Parameters

Condition Stage III Non-small Cell Lung Cancer
Sponsor Sun Yat-sen University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 116
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2022-01-01
Completion 2024-12-30
Interventions
Neoadjuvant chemo-immunotherapyBevacizumabRadiotherapy

Brief 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 Criteria

Inclusion Criteria: * For inclusion in neoadjuvant therapy, patients should fulfil the following criteria: * Provision of signed, written and dated informed consent prior to any study specific procedures; * Male or female aged 18\~75 years old; * Patients must have histologically- or cytologically-documented NSCLC who present with locally advanced (Stage III) disease; * Without prior chemotherapy, radiotherapy, surgery, targeted therapy or immunotherapy; * A recent tumour biopsy (taken following completion of the most recent therapy) is an optional requirement, provided that a biopsy procedure is technically feasible and the procedure is not associated with unacceptable clinical risk; * Life expectancy ≥12 weeks; * World Health Organization (WHO) Performance Status of 0 or 1; * Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients within 14 days before the use of study drug (HCG has a minimum sensitivity of 25 IU/L or equival

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