This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of surufatinib and tislelizumab in combination with concurrent chemoradiotherapy, followed by consolidation therapy with tislelizumab plus surufatinib, in patients with unresectable, locally advanced stage III non-small cell lung cancer (NSCLC).
A written and dated informed consent form must be obtained prior to the initiation of any study-specific procedures.
Male or female patients aged 18 to 75 years.
Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer (NSCLC) (Stage IIIA-IIIC).
Tumor sample requirement: Adequate archival, unstained tumor tissue samples must be provided for analysis.
Participation in another clinical study, unless it is an observational (non-interventional) study.
Histological diagnosis of combined small cell and non-small cell lung cancer.
Presence of EGFR or ALK driver gene mutations.
Any condition that may affect oral medication administration (e.g., dysphagia, chronic diarrhea, bowel obstruction).
Single group
Surufatinib
DrugAdministered orally at 200 mg once daily d1-d14, starting at the initiation of each radiotherapy phase, for 14 consecutive days. Six weeks after completion of concurrent chemoradiotherapy, patients meeting the eligibility criteria will receive consolidation therapy with surufatinib 200 mg orally once daily on Days 1-14 of each 21-day cycle
Tislelizumab
Drug200 mg administered via intravenous drip one day prior to the start of each radiotherapy phase. Six weeks after completion of concurrent chemoradiotherapy, patients meeting the eligibility criteria will receive consolidation therapy with tislelizumab 200 mg administered via intravenous drip on Day 1 of each cycle (Q3W), for up to 12 months.
Concurrent Chemotherapy
DrugAlbumin-bound paclitaxel 50 mg/m² plus cisplatin 25 mg/m², administered weekly (QW).
Radiotherapy
Radiationdefinitive hypofractionated radiotherapy
2-year progression-free survival rate
The 2-year progression-free survival rate refers to the proportion of patients who remain alive without evidence of disease progression at 24 months after initiation of treatment.
Overall survival (OS)
The time from the start of treatment to death from any cause.
Objective Response Rate (ORR)
The objective response rate refers to the proportion of patients with a measurable reduction in tumor burden, including complete response (CR) and partial response (PR), as defined by standardized criteria such as RECIST (Response Evaluation Criteria in Solid Tumors).
Treatment-related adverse events
The assessment of treatment-related adverse events (AEs), including their type, severity, frequency, and impact on patients.
Patient-reported quality of life
Quality of life assessed using the EORTC Quality of Life Core Questionnaire (QLQ-C30).
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