Phase II Study of Surufatinib and Tislelizumab with Concurrent Chemoradiotherapy in Adults Aged 18 to 75 with Locally Advanced Unresectable Non-Small Cell Lung Cancer
Led by Sun Yat-sen University · Updated on 2025-07-25
80
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining surufatinib and tislelizumab with concurrent chemoradiotherapy in patients who have unresectable, locally advanced stage III non-small cell lung cancer NSCLC. This phase II clinical trial aims to explore how this combination treatment, followed by consolidation therapy, may impact disease progression and survival outcomes for these patients.
All participants will first receive concurrent chemoradiotherapy along with surufatinib and tislelizumab. Surufatinib is taken orally at 200 mg once daily for two weeks followed by a one-week break, forming a 21-day treatment cycle. Tislelizumab is given via intravenous infusion at 200 mg every three weeks, continuing for up to 12 months. Patients who show complete response, partial response, or stable disease after this initial treatment phase will continue with consolidation therapy using surufatinib and tislelizumab.
During the study, participants will undergo assessments including tumor response evaluations, survival monitoring, and quality of life questionnaires. Researchers will also track treatment-related side effects and changes in minimal residual disease over time. The main outcome measured is the progression-free survival rate at two years. The study will follow participants for up to two years to gather comprehensive data on treatment effects and safety.
CONDITIONS
Brief Title
Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer
Research Team
B
Bo Qiu
H
Hui Liu, Professor
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer (Stage IIIA-IIIC)
Adequate archival, unstained tumor tissue samples available for analysis
Expected life expectancy of at least 12 weeks
WHO performance status score of 0 or 1
Postmenopausal women, or negative pregnancy test within 14 days before study treatment
Female participants must not be breastfeeding
Women of childbearing potential and sexually active male participants must agree to use effective contraception during treatment and for 6 months after
Adequate organ and bone marrow function based on specified laboratory criteria
You will not qualify if you...
Participation in another clinical study, except observational studies
Histological diagnosis of combined small cell and non-small cell lung cancer
Major surgery within 4 weeks before study entry (excluding vascular access)
QTc interval of 470 ms or more
Uncontrolled comorbidities such as active infections, heart failure, hypertension, angina, arrhythmias, bleeding disorders, or certain viral infections
Psychiatric or social conditions interfering with study compliance or consent
History of another primary cancer within 5 years, except certain skin or cervical cancers
Pregnant or breastfeeding women; or those not using effective contraception
Use of immunosuppressive medications within 28 days prior to first dose of tislelizumab, with some exceptions
History or active autoimmune disease within 2 years
History of inflammatory bowel disease or primary immunodeficiency
History of organ transplantation requiring immunosuppressive therapy
Live attenuated vaccine within 30 days before or after starting study
Any condition that may interfere with study treatment assessment as judged by the investigator
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Concurrent chemoradiotherapy duration plus up to 12 months of consolidation therapy
Participants receive definitive concurrent chemoradiotherapy combined with surufatinib and tislelizumab. Surufatinib is taken orally for 14 consecutive days followed by a 1-week break in each 21-day cycle. Tislelizumab is administered intravenously every 3 weeks. Concurrent chemotherapy with albumin-bound paclitaxel and cisplatin is given weekly, alongside hypofractionated radiotherapy.
Weekly visits during chemoradiotherapy and then visits every 3 weeks during consolidation therapy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Using 3-D Virtual Lung Resection to Predict Lung Function After VATS Surgery for Non-Small Cell Lung Cancer
Early Evaluation of Neoadjuvant Immunotherapy Response
Using 68Ga-grazytracer PETCT in Resectable Non-Small Cell Lung Cancer
Patients Aged 18 to 75 Years
Phase 3 Study of Calderasib with Subcutaneous Pembrolizumab and Berahyaluronidase Alfa Versus Pembrolizumab with Chemotherapy for KRAS G12C-Mutant Advanced Non-Small Cell Lung Cancer
Phase III Trial to Evaluate Adjuvant Cemiplimab Immunotherapy After Surgery in Adults With Stage II-IIIA Non-Small Cell Lung Cancer Who Have Not Had Chemotherapy
Phase 3 Trial of Intismeran With or Without Pembrolizumab and Berahyaluronidase Alfa as Adjuvant Therapy in High-Risk Stage I Non-Small Cell Lung Cancer After Surgery
Study of Calderasib and Durvalumab Versus Placebo and Durvalumab in Adults With Locally Advanced KRAS G12C-Mutant Non-Small Cell Lung Cancer After Chemoradiotherapy
Phase 2 Study of TQB2102 Injection for Treating Locally Advanced or Metastatic Non-Small Cell Lung Cancer with HER2 Gene Abnormality
Phase I Study of Intravenous CEA-Targeted CAR-T Therapy for Advanced CEA Positive Solid Tumors
Phase 1b2 Study to Find Safe Dose and Test Effectiveness of BNT326 and Pumitamig Combination in Adults with Advanced Non-small Cell Lung Cancer
Phase IIIb Study to Evaluate the Safety and Effectiveness of Vebreltinib PLB1001 in Adults With Advanced or Metastatic Non-Small Cell Lung Cancer Having MET Exon 14 Mutation
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Efficacy and safety of surufatinib plus toripalimab, a chemotherapy-free regimen, in patients with advanced gastric/gastroesophageal junction adenocarcinoma, esophageal squamous cell carcinoma, or biliary tract cancer.
Surufatinib plus toripalimab combined with etoposide and cisplatin as first-line treatment in advanced small-cell lung cancer patients: a phase Ib/II trial.