RecruitingPhase 2NCT05758116

Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients

A Prospective, Open-label, Single-arm, Phase II Trial Investigating the Efficacy and Safety of Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients

Sponsor

Peking University Cancer Hospital & Institute

Enrollment

20 participants

Start Date

Jul 7, 2022

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer Consolidation Immunotherapy Radiotherapy or Sequential Chemoradiation

Summary

The current standard of care for locally advanced non-small cell lung cancer (NSCLC) is concurrent chemoradiation and consolidation immunotherapy. In real world clinical practice, patients who cannot tolerate concurrent chemoradiation generally received radiotherapy alone or sequential chemoradiation. These patients are more likely to develop distant metastases and therefore may require tolerable systemic consolidation regimens. However, there is a lack of evidence from clinical studies on consolidation immunotherapy after radiotherapy alone or sequential chemoradiation. The aim of the study is to explore the efficacy and safety of Tislelizumab consolidation therapy after radiotherapy or sequential chemoradiation in locally advanced NSCLC patients who are intolerable of concurrent concurrent chemoradiation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing tislelizumab (an immune checkpoint inhibitor) as consolidation therapy — maintenance treatment after radiation is complete — in patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) who cannot tolerate concurrent chemoradiation and have not progressed after their initial treatment. **You may be eligible if...** - You have stage III non-small cell lung cancer that cannot be surgically removed (or you are unable or unwilling to have surgery) - You cannot tolerate concurrent chemoradiation (radiation and chemotherapy given at the same time) - You completed sequential chemotherapy followed by radiation without the cancer progressing - Your chemotherapy and radiation met specific standards (standard drug combinations, IMRT/VMAT radiation technique) **You may NOT be eligible if...** - Your cancer has progressed during or after radiation - You can tolerate concurrent chemoradiation - Your cancer is small cell lung cancer or a type other than NSCLC - Your treatment did not follow the required protocols 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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