Hypofractionated Chemoradiotherapy With Tislelizumab and Surufatinib for Unresectable Stage III NSCLC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

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

Qualifiers

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

Treatments tested in this trial

  • Radiotherapy
  • Concurrent chemotherapy
  • Tislelizumab
  • Surufatinib

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators