Actively Recruiting
Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer
Led by Sun Yat-sen University · Updated on 2025-07-25
80
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent before any study procedures
- Male or female aged 18 to 75 years
- Histologically or cytologically confirmed locally advanced, unresectable NSCLC (Stage IIIA-IIIC)
- Provided adequate archival, unstained tumor tissue samples 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 medication
- Female participants must not be breastfeeding
- Women of childbearing potential must agree to use effective contraception during the study and for 6 months after last dose
- Male participants who are sexually active with women of childbearing potential must agree to use effective contraception during the study and for 6 months after last dose
- Male participants with azoospermia are exempt from contraceptive requirements
- Women of childbearing potential not heterosexually active are exempt from contraceptive use but must undergo pregnancy testing
- Adequate organ and bone marrow function including FEV1 800 mL; ANC 1.5 x 10�7/L; platelet count 100 x 10�7/L; hemoglobin 9.0 g/dL; creatinine clearance 50 mL/min; total bilirubin 1.5 x ULN; AST and ALT 2.5 x ULN
You will not qualify if you...
- Participation in another clinical study except observational (non-interventional) studies
- Diagnosis of combined small cell and non-small cell lung cancer
- Presence of EGFR or ALK driver gene mutations
- Conditions affecting oral medication intake such as dysphagia, chronic diarrhea, bowel obstruction
- Major surgery within 4 weeks before study entry (except vascular access procedures)
- QTc interval 470 ms on ECG
- Uncontrolled comorbidities including active infections, symptomatic heart failure, uncontrolled hypertension, unstable angina, arrhythmias, active peptic ulcer or bleeding disorders, active hepatitis B with high viral load, hepatitis C, HIV infection
- Psychiatric or social conditions interfering with compliance or consent
- History of other primary cancer within 5 years except treated basal or squamous skin cancer or carcinoma in situ of cervix
- Pregnant or breastfeeding women, or men and women not using effective contraception
- Use of immunosuppressive drugs within 28 days prior to first tislelizumab dose except low dose corticosteroids
- History or active autoimmune disease within past 2 years
- History or active inflammatory bowel disease
- History of primary immunodeficiency
- History of organ transplantation requiring immunosuppressive therapy
- Receipt of live attenuated vaccine within 30 days before study or within 30 days after tislelizumab
- Any condition that may interfere with safety or efficacy assessment as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
B
Bo Qiu
CONTACT
H
Hui Liu, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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