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Taking people in ChinaPhase 2

Shorter radiation with chemotherapy and two drugs for lung cancer

Tests tislelizumab with or without surufatinib alongside radiation in adults with lung cancer.

Key facts

Who runs it
Sun Yat-sen University
Where
Guangzhou, ChinaSee the site
Trial code
Registry title
Hypofractionated Chemoradiotherapy With Tislelizumab and Surufatinib for Unresectable Stage III NSCLC
Status
Recruiting
Phase
Phase 2
People taking part
160 people, planned
Started
1 Jun 2026
Expected to end
31 May 2029
Type of study
Interventional, 2 groups
Treatments tested
  • Radiotherapy
  • Concurrent chemotherapy
  • Tislelizumab
  • Surufatinib
Record updated
1 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with non-small cell lung cancer (NSCLC) that cannot be removed by surgery and has reached stage III, with no known driver gene changes.

Age
18 to 75 years
Sex
Women and men can join.
Disease stage
Non-small cell lung cancer, unresectable stage III (AJCC 8th staging system). Not a mixed small cell and non-small cell cancer.
Earlier treatment
Newly diagnosed, or treated with 4 or fewer cycles of chemotherapy with or without immunotherapy.
Biomarker or test result
No known driver gene mutations.

Main reasons for not taking part

  • Active or past autoimmune disease in the last 2 years, or inflammatory bowel disease
  • Past organ transplant needing immune-suppressing treatment, or primary immunodeficiency
  • Hepatitis B, hepatitis C, HIV, active infection or other uncontrolled illness
  • Known history of tuberculosis
  • Another cancer within the last 5 years (some skin and cervical cancers excepted)

The registry criteria, word for word

Show all 28 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study
  • Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access
  • Active or prior documented autoimmune disease within the past 2 years
  • Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis)
  • History of another primary malignancy within 5 years prior to starting treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study
  • Mixed small cell and non-small cell lung cancer histology
  • History of primary immunodeficiency
  • History of organ transplant that requires therapeutic immunosuppression
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
  • Known history of tuberculosis
  • Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Hui Liu, DoctorTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Study group ATreatment being tested

    Patients will receive hypofractionated thoracic radiotherapy with concurrent chemotherapy, combined with tislelizumab and surufatinib during radiotherapy. Patients who achieve complete response, partial response, or stable disease after chemoradiotherapy will receive consolidation therapy with tislelizumab and surufatinib for up to one year.

    Treatment: Radiotherapy, Concurrent chemotherapy, Tislelizumab, and Surufatinib

  • Study group BTreatment being tested

    Patients will receive hypofractionated thoracic radiotherapy with concurrent chemotherapy, combined with tislelizumab during radiotherapy. Patients who achieve complete response, partial response, or stable disease after chemoradiotherapy will receive consolidation therapy with tislelizumab for up to one year.

    Treatment: Radiotherapy, Concurrent chemotherapy, and Tislelizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized Phase 2 Study of Hypofractionated Concurrent Chemoradiotherapy Combined With Tislelizumab and Surufatinib in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Plain-language title
Shorter radiation with chemotherapy and two drugs for lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07609121, who can take part
Record updated
1 July 2026