About this trial
This phase II trial employs a prospective, randomized, parallel-group design to evaluate the efficacy and safety of hypofractionated radiotherapy combined with tislelizumab and surufatinib. Eligible patients are randomly assigned to one of two arms: Experimental Group A receives hypofractionated chemoradiotherapy plus concurrent tislelizumab and surufatinib, followed by consolidation therapy with tislelizumab plus surufatinib; Experimental Group B receives the same hypofractionated chemoradiotherapy plus concurrent tislelizumab alone, followed by tislelizumab consolidation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females aged 18 to 75 years or older;
Patients must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC);
Unresectable Stage III disease according to AJCC 8th staging system;
Negative for known driver gene mutations;
Disqualifiers
Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study;
Mixed small cell and non-small cell lung cancer histology;
Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access;
Active or prior documented autoimmune disease within the past 2 years;
Trial design
Parallel
Treatments tested in this trial
Radiotherapy
RadiationSplit-course hypofractionated thoracic radiotherapy
Concurrent chemotherapy
DrugWeekly nab-paclitaxel and cisplatin during radiotherapy
Tislelizumab
DrugTislelizumab 200mg every three weeks during and following radiotherapy
Surufatinib
DrugSurufatinib during and following radiotherapy
Treatment groups
Trial outcomes
Primary outcomes
Progression-free survival
The time from randomization to the first documented disease progression or death from any cause, whichever occurs first.
Secondary outcomes
Overall survival
The time from randomization to death from any cause, censored at the last follow-up date.
Treatment related toxicity
Graded by CTCAE 5.0
Sponsors and contacts
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