NCT07086456

Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer

Evaluating the Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer: A Prospective, Single-Arm Phase II Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Surufatinib
• Tislelizumab
• Concurrent Chemoradiotherapy
• Consolidation Therapy
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Surufatinib	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
DRUG	Tislelizumab	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.
DRUG	Concurrent Chemotherapy	Albumin-bound paclitaxel 50 mg/m² plus cisplatin 25 mg/m², administered weekly (QW).
RADIATION	Radiotherapy	definitive hypofractionated radiotherapy

Timeline

• Start date: 2025-07-20
• Primary completion: 2029-07-19
• Completion: 2029-07-19
• First posted: 2025-07-25
• Last updated: 2025-07-25

Locations

1 site across 1 country: China