Hypofractionated Chemoradiotherapy With Tislelizumab and Surufatinib for Unresectable Stage III N… (NCT07609121) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Hypofractionated Chemoradiotherapy With Tislelizumab and Surufatinib for Unresectable Stage III NSCLC
China160 participantsStarted 2026-06-01
Plain-language summary
This phase II trial employs a prospective, randomized, parallel-group design to evaluate the efficacy and safety of hypofractionated radiotherapy combined with tislelizumab and surufatinib. Eligible patients are randomly assigned to one of two arms: Experimental Group A receives hypofractionated chemoradiotherapy plus concurrent tislelizumab and surufatinib, followed by consolidation therapy with tislelizumab plus surufatinib; Experimental Group B receives the same hypofractionated chemoradiotherapy plus concurrent tislelizumab alone, followed by tislelizumab consolidation.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males or females aged 18 to 75 years or older;
* Patients must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC);
* Unresectable Stage III disease according to AJCC 8th staging system;
* Negative for known driver gene mutations；
* Newly diagnosed patients or patients treated with ≤ 4 cycles of chemotherapy combined with or without immunotherapy;
* Expected survival ≥ 12 weeks;
* WHO Performance Status (PS) score of 0 or 1;
* Female subjects must not be breastfeeding;
* Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment and for 5 months after the last dose of study drug (i.e., 30 days \[one ovulation cycle\] plus approximately five half-lives of the study drug);
* Adequate organ and bone marrow function as defined by the following criteria:
* Forced Expiratory Volume in 1 second (FEV1) ≥ 800 mL;
* Absolute neutrophil count ≥ 1.5 × 10⁹/L;
* Platelets ≥ 100 × 10⁹/L;
* Hemoglobin ≥ 9.0 g/dL;
* Creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976);
* Serum bilirubin ≤ 1.5 × upper limit of normal (ULN);
* AST and ALT ≤ 2.5 × ULN.
Exclusion Criteria:
* Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study;
* Mixed small cell and non-small cell lung cancer histology;
* Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.