RecruitingPhase 2NCT07086456

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

Sponsor

Sun Yat-sen University

Enrollment

80 participants

Start Date

Jul 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a triple combination treatment — chemoradiation (chemotherapy plus radiation), surufatinib (a drug that blocks blood supply to tumors), and tislelizumab (an immunotherapy drug) — for patients with locally advanced non-small cell lung cancer (NSCLC) that cannot be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with locally advanced, unresectable NSCLC (Stage IIIA to IIIC) confirmed by biopsy - You have not received prior treatment for this cancer - Your overall health is good (performance status 0 or 1) and expected survival is at least 12 weeks **You may NOT be eligible if...** - You have already received chemotherapy, radiotherapy, or immunotherapy for this cancer - Your tumor has specific driver gene mutations requiring targeted therapy - You have active autoimmune disease or uncontrolled infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSurufatinib

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

DRUGTislelizumab

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.

DRUGConcurrent Chemotherapy

Albumin-bound paclitaxel 50 mg/m² plus cisplatin 25 mg/m², administered weekly (QW).

RADIATIONRadiotherapy

definitive hypofractionated radiotherapy

Locations(1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT07086456

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