OncoMatch/Clinical Trials/NCT05758116
Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients
Is NCT05758116 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Tislelizumab for non-small cell lung cancer.
Treatment: Tislelizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR sensitizing mutation (wild-type)
Patients with EGFR-sensitive mutations ... [excluded]
Required: ALK rearrangement (wild-type)
Patients with ... ALK rearrangements [excluded]
Required: PD-L1 (CD274) overexpression (PD-L1 ≥1%)
PD-L1≥1%
Disease stage
Required: Stage III (AJCC 8th)
stage III(AJCC 8th) unresectable NSCLC, or resectable but intolerant or refusing surgery
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemoradiation (paclitaxel, pemetrexed, gemcitabine, platinum) — concurrent or sequential
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
Cannot have received: anti-PD-1 therapy
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)
Lab requirements
Blood counts
Adequate Hematologic, biochemistry and organ function (to be confirmed by test results within 7 days prior to the first dose)
Kidney function
serum creatinine > 1.5x ULN
Liver function
total bilirubin > 1.5x ULN; ALT/AST > 2.5x ULN in patients without liver metastases and ALT/AST > 5x ULN in patients with liver metastases
Adequate Hematologic, biochemistry and organ function (to be confirmed by test results within 7 days prior to the first dose); Abnormal liver function [total bilirubin > 1.5x ULN; ALT/AST > 2.5x ULN in patients without liver metastases and ALT/AST > 5x ULN in patients with liver metastases], abnormal renal function (serum creatinine > 1.5x ULN)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05758116 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1 therapy disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR sensitizing mutation is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK rearrangement is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify