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
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.
• Patients with stage III(AJCC 8th) unresectable NSCLC, or resectable but intolerant or refusing surgery;
• Intolerable of concurrent chemoradiation;
• No progression after radiotherapy or sequential chemoradiation;
• Chemotherapy: standard dose of 2-6 cycles of paclitaxel, pemetrexed or gemcitabine in combination with platinum; Radiotherapy: starting within 3 months after chemotherapy using IMRT or VMAT technique. The target volume includes the primary tumor and regional lymph nodes, and the prescription dose 95% PTV ranges from 50Gy to 66Gy;
• ECOG PS0-2;
• PD-L1≥1%;
• Age≥18 years, and life expectancy\>3 months;
• Adequate Hematologic, biochemistry and organ function (to be confirmed by test results within 7 days prior to the first dose);
• Be able to provide written informed consent (ICF) and able to understand and agree to comply with study requirements and assessment schedule.