NSCLC (Non-small Cell Lung Cancer)Phase 2NCT07609121
Hypofractionated Chemoradiotherapy With Tislelizumab and Surufatinib for Unresectable Stage III NSCLC
A Phase 2 study testing Radiotherapy, Concurrent chemotherapy and Tislelizumab in people with NSCLC (Non-small Cell Lung Cancer), run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer)
- What is being tested?
- Radiotherapy, Concurrent chemotherapy and Tislelizumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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 join
- 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 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 primary immunodeficiency;
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- 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;
- 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;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Hui Liu, Doctor, +862087343031, liuhuisysucc@126.com
About this study
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
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.
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Being tested
- Radiotherapy, Concurrent chemotherapy, Tislelizumab, Surufatinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Split-course hypofractionated thoracic radiotherapy
Concurrent chemotherapyDrug
Weekly nab-paclitaxel and cisplatin during radiotherapy
TislelizumabDrug
Tislelizumab 200mg every three weeks during and following radiotherapy
SurufatinibDrug
Surufatinib during and following radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Study group A | Experimental | 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. Receives: Radiation: Radiotherapy; Drug: Concurrent chemotherapy; Drug: Tislelizumab; Drug: Surufatinib |
| Study group B | Experimental | 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. Receives: Radiation: Radiotherapy; Drug: Concurrent chemotherapy; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The time from randomization to the first documented disease progression or death from any cause, whichever occurs first.
Measured: 18-month
Secondary outcomes (2)
Overall survival
The time from randomization to death from any cause, censored at the last follow-up date.
Measured: 18-month
Treatment related toxicity
Graded by CTCAE 5.0
Measured: 18-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jun 2026
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Liu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609121
- Sponsor's protocol ID
- A2025-007
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07609121
- Acronym / sponsor ID
- A2025-007
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group A | Experimental | Radiation: Radiotherapy, Drug: Concurrent chemotherapy, Drug: Tislelizumab, Drug: SurufatinibPatients 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. |
| Study group B | Experimental | Radiation: Radiotherapy, Drug: Concurrent chemotherapy, Drug: TislelizumabPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (11 listed)
- 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 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapySplit-course hypofractionated thoracic radiotherapy | Radiation | Study group A, Study group B |
| Concurrent chemotherapyWeekly nab-paclitaxel and cisplatin during radiotherapy | Drug | Study group A, Study group B |
| TislelizumabTislelizumab 200mg every three weeks during and following radiotherapy | Drug | Study group A, Study group B |
| SurufatinibSurufatinib during and following radiotherapy | Drug | Study group A |
Primary outcome
Progression-free survival
Time frame: 18-month
The time from randomization to the first documented disease progression or death from any cause, whichever occurs first.
2 secondary outcomes
Overall survival
Time frame: 18-month
Treatment related toxicity
Time frame: 18-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy, Concurrent chemotherapy and Tislelizumab in people with NSCLC (Non-small Cell Lung Cancer), run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DaQuan Wang, MD (+862087343031, wangdq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 18-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.