A Phase 2 interventional study of Surufatinib and Tislelizumab in Surufatinib, Tislelizumab and Concurrent Chemoradiotherapy, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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).
In this study, all enrolled patients will initially receive definitive concurrent chemoradiotherapy combined with surufatinib and tislelizumab. Patients who achieve complete response (CR), partial response (PR), or stable disease (SD) following the aforementioned treatment will proceed to receive consolidation therapy with surufatinib and tislelizumab. Surufatinib will be administered orally at a dose of 200 mg once daily (QD) for 2 consecutive weeks followed by a 1-week break, with each cycle lasting 3 weeks (21 days). Concurrently, tislelizumab will be administered intravenously at 200 mg every 3 weeks (Q3W), for up to a maximum duration of 12 months.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 80 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Exclusion Criteria:
In this study, all enrolled patients will initially receive definitive concurrent chemoradiotherapy combined with surufatinib and tislelizumab. Patients who achieve complete response (CR), partial response (PR), or stable disease (SD) following the aforementioned treatment will proceed to receive consolidation therapy with surufatinib and tislelizumab. Surufatinib will be administered orally at a dose of 200 mg once daily (QD) for 2 consecutive weeks followed by a 1-week break, with each cycle lasting 3 weeks (21 days). Concurrently, tislelizumab will be administered intravenously at 200 mg every 3 weeks (Q3W), for up to a maximum duration of 12 months.
Drug: Surufatinib · Drug: Tislelizumab · Drug: Concurrent Chemotherapy · Radiation: Radiotherapy
Administered 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
200 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.
Albumin-bound paclitaxel 50 mg/m² plus cisplatin 25 mg/m², administered weekly (QW).
definitive 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.
Time frame: 2 years
Overall survival (OS)
The time from the start of treatment to death from any cause.
Time frame: 2 years
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).
Time frame: 6 weeks after CCRT
Treatment-related adverse events
The assessment of treatment-related adverse events (AEs), including their type, severity, frequency, and impact on patients.
Time frame: 1 year after treatment
Patient-reported quality of life
Quality of life assessed using the EORTC Quality of Life Core Questionnaire (QLQ-C30).
Time frame: 1 year after treatment
Patient-reported lung cancer-specific symptoms
Lung cancer-related symptoms assessed using the European Organisation for Research and Treatment of Cancer Lung Cancer Module (EORTC QLQ-LC13).
Time frame: 1 year after treatment
Dynamic Changes in Minimal Residual Disease (MRD)
Longitudinal Monitoring of Circulating Tumor DNA (ctDNA)-Based MRD in Blood
Time frame: 1 year
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Carcinoma, Non-Small-Cell Lung→
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