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;
Patients with EGFR-sensitive mutations and ALK rearrangements;
Any prior use of anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies (including Ipilimumab or any other antibody targeting the T-cell co-stimulation or checkpoint pathway);
History of allergy to components of Tislelizumab;
Any active malignancy within 2 years prior to enrollment, except for the specific cancers examined in this study and any locally recurrent cancers that have been eradicated (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ);
Single group
Tislelizumab
DrugTislelizumab: 200mg d1,q21d\*17
Progression-free survival
Defined from the date of enrollment to the date of death or any recurrence.
Overall survival
Defined from the date of enrollment to the date of death.
Objective response rate
Defined as the occurrence of a complete or partial response per RECIST 1.1 criteria.
Treatment-related adverse events
Graded according to NCI-CTCAE v5.0
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