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SurufatinibPhase 2NCT07086456

Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer

A Phase 2 study testing Surufatinib, Tislelizumab and Concurrent Chemotherapy in people with Surufatinib and Tislelizumab, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Surufatinib, Tislelizumab and Concurrent Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
20 Jul 2025to 19 Jul 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

  • A written and dated informed consent form must be obtained prior to the initiation of any study-specific procedures.
  • Male or female patients aged 18 to 75 years.
  • Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer (NSCLC) (Stage IIIA-IIIC).
  • Tumor sample requirement: Adequate archival, unstained tumor tissue samples must be provided for analysis.
  • Expected life expectancy of ≥12 weeks.
  • World Health Organization (WHO) performance status (PS) score of 0 or 1.
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  • Postmenopausal women, or negative urine or serum pregnancy test (with a minimum sensitivity of 25 IU/L or equivalent for HCG) within 14 days prior to receiving study medication.
  • Female participants must not be breastfeeding.
  • Women of childbearing potential (WOCBP) must agree to use effective contraception during the study treatment period and for 6 months after the last dose of study drug.
  • Male participants who are sexually active with WOCBP must agree to use effective contraception during the study treatment period and for 6 months after the last dose of study drug.
  • Male participants with azoospermia are exempt from contraceptive requirements. WOCBP who are not heterosexually active are also exempt from contraceptive use but must still undergo pregnancy testing as specified above.
  • Adequate organ and bone marrow function as defined by the following criteria: Forced expiratory volume in 1 second (FEV1) ≥ 800 mL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 9.0 g/dL; Serum creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula; Cockcroft and Gault, 1976); Total serum bilirubin ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN

Who cannot join

  • Participation in another clinical study, unless it is an observational (non-interventional) study.
  • Histological diagnosis of combined small cell and non-small cell lung cancer.
  • Presence of EGFR or ALK driver gene mutations.
  • Any condition that may affect oral medication administration (e.g., dysphagia, chronic diarrhea, bowel obstruction).
  • Major surgery within 4 weeks prior to study entry (excluding vascular access procedures).
  • Average QT interval corrected for heart rate (QTc) ≥ 470 ms, calculated using Bazett's formula from three ECG cycles.
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  • Uncontrolled comorbidities, including but not limited to: ongoing or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, clinically significant arrhythmias, active peptic ulcer disease or gastritis, active bleeding disorders, or patients who are HBsAg-positive with HBV DNA > 500 IU/mL, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection. Also excluded are individuals with psychiatric or social conditions that may interfere with study compliance or the ability to provide written informed consent.
  • History of another primary malignancy within 5 years prior to study treatment initiation, except for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Pregnant or breastfeeding women; or women and men of reproductive potential who are not using effective contraception.
  • Use of immunosuppressive medications within 28 days prior to the first dose of tislelizumab, excluding intranasal corticosteroids at physiological doses and systemic corticosteroids at a dose equivalent to ≤10 mg/day of prednisone.
  • History of autoimmune disease or active autoimmune disease within the past 2 years.
  • Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
  • History of primary immunodeficiency.
  • History of organ transplantation requiring immunosuppressive therapy.
  • Receipt of a live attenuated vaccine within 30 days prior to study initiation or within 30 days after receiving tislelizumab.
  • Any condition that, in the investigator's judgment, may interfere with the assessment of efficacy or safety of the study treatment.

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
  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Hui Liu, Professor, 02087343031, liuhui@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: Evaluating the Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer: A Prospective, Single-Arm Phase II Clinical Trial

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).

Read the detailed description

In this study, all enrolled patients will initially receive definitive concurrent chemoradiotherapy combined with surufatinib and tislelizumab. Patients who achieve complete response (CR), partial response (PR), or stable disease (SD) following the aforementioned treatment will proceed to receive consolidation therapy with surufatinib and tislelizumab. Surufatinib will be administered orally at a dose of 200 mg once daily (QD) for 2 consecutive weeks followed by a 1-week break, with each cycle lasting 3 weeks (21 days). Concurrently, tislelizumab will be administered intravenously at 200 mg every 3 weeks (Q3W), for up to a maximum duration of 12 months.

Being tested
Surufatinib, Tislelizumab, Concurrent Chemotherapy, Radiotherapy
Keywords
surufatinib, tislelizumab, concurrent chemoradiotherapy, consolidation therapy, non-small cell lung cancer
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.

  • SurufatinibDrug

    Administered orally at 200 mg once daily d1-d14, starting at the initiation of each radiotherapy phase, for 14 consecutive days. Six weeks after completion of concurrent chemoradiotherapy, patients meeting the eligibility criteria will receive consolidation therapy with surufatinib 200 mg orally once daily on Days 1-14 of each 21-day cycle

  • TislelizumabDrug

    200 mg administered via intravenous drip one day prior to the start of each radiotherapy phase. Six weeks after completion of concurrent chemoradiotherapy, patients meeting the eligibility criteria will receive consolidation therapy with tislelizumab 200 mg administered via intravenous drip on Day 1 of each cycle (Q3W), for up to 12 months.

  • Concurrent ChemotherapyDrug

    Albumin-bound paclitaxel 50 mg/m² plus cisplatin 25 mg/m², administered weekly (QW).

  • RadiotherapyRadiation

    definitive hypofractionated radiotherapy

Study groups in NCT07086456
Study groupRoleWhat they receive
Study groupExperimentalIn this study, all enrolled patients will initially receive definitive concurrent chemoradiotherapy combined with surufatinib and tislelizumab. Patients who achieve complete response (CR), partial response (PR), or stable disease (SD) following the aforementioned treatment will proceed to receive consolidation therapy with surufatinib and tislelizumab. Surufatinib will be administered orally at a dose of 200 mg once daily (QD) for 2 consecutive weeks followed by a 1-week break, with each cycle lasting 3 weeks (21 days). Concurrently, tislelizumab will be administered intravenously at 200 mg every 3 weeks (Q3W), for up to a maximum duration of 12 months.
Receives: Drug: Surufatinib; Drug: Tislelizumab; Drug: Concurrent Chemotherapy; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year progression-free survival rate

    The 2-year progression-free survival rate refers to the proportion of patients who remain alive without evidence of disease progression at 24 months after initiation of treatment.

    Measured: 2 years

Secondary outcomes (6)
  1. Overall survival (OS)

    The time from the start of treatment to death from any cause.

    Measured: 2 years

  2. Objective Response Rate (ORR)

    The objective response rate refers to the proportion of patients with a measurable reduction in tumor burden, including complete response (CR) and partial response (PR), as defined by standardized criteria such as RECIST (Response Evaluation Criteria in Solid Tumors).

    Measured: 6 weeks after CCRT

  3. Treatment-related adverse events

    The assessment of treatment-related adverse events (AEs), including their type, severity, frequency, and impact on patients.

    Measured: 1 year after treatment

  4. Patient-reported quality of life

    Quality of life assessed using the EORTC Quality of Life Core Questionnaire (QLQ-C30).

    Measured: 1 year after treatment

  5. Patient-reported lung cancer-specific symptoms

    Lung cancer-related symptoms assessed using the European Organisation for Research and Treatment of Cancer Lung Cancer Module (EORTC QLQ-LC13).

    Measured: 1 year after treatment

  6. Dynamic Changes in Minimal Residual Disease (MRD)

    Longitudinal Monitoring of Circulating Tumor DNA (ctDNA)-Based MRD in Blood

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study start20 Jul 2025 (estimated)
  3. Primary completion19 Jul 2029 (estimated)
  4. Study completion19 Jul 2029 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07086456
Sponsor's protocol ID
GASTO-10131
Status last verified
Jul 2025
First submitted
15 Jul 2025
Last updated
25 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang Y, Huang Y, Yang Y, Zhao Y, Zhou T, Chen G, Zhao S, Zhou H, Ma Y, Hong S, Zhao H, Zhang L, Fang W. Surufatinib plus toripalimab combined with etoposide and cisplatin as first-line treatment in advanced small-cell lung cancer patients: a phase Ib/II trial. Signal Transduct Target Ther. 2024 Sep 27;9(1):255. doi: 10.1038/s41392-024-01974-2.

    PubMed 39327433
  • Zhang P, Chen Z, Shi S, Li Z, Ye F, Song L, Zhang Y, Yin F, Zhang X, Xu J, Cheng Y, Su W, Shi M, Fan S, Tan P, Zhong C, Lu M, Shen L. 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. Cancer Immunol Immunother. 2024 May 7;73(7):119. doi: 10.1007/s00262-024-03677-7.

    PubMed 38713205
  • Xu J, Shen L, Zhou Z, Li J, Bai C, Chi Y, Li Z, Xu N, Li E, Liu T, Bai Y, Yuan Y, Li X, Wang X, Chen J, Ying J, Yu X, Qin S, Yuan X, Zhang T, Deng Y, Xiu D, Cheng Y, Tao M, Jia R, Wang W, Li J, Fan S, Peng M, Su W. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Nov;21(11):1500-1512. doi: 10.1016/S1470-2045(20)30496-4. Epub 2020 Sep 20.

    PubMed 32966811
  • Xu J, Shen L, Bai C, Wang W, Li J, Yu X, Li Z, Li E, Yuan X, Chi Y, Yin Y, Lou W, Xu N, Bai Y, Zhang T, Xiu D, Wang X, Yuan Y, Chen J, Qin S, Jia R, Lu M, Cheng Y, Zhou Z, Li J, He J, Su W. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Nov;21(11):1489-1499. doi: 10.1016/S1470-2045(20)30493-9. Epub 2020 Sep 20.

    PubMed 32966810
  • Syed YY. Surufatinib: First Approval. Drugs. 2021 Apr;81(6):727-732. doi: 10.1007/s40265-021-01489-y.

    PubMed 33788183
  • Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, Spigel DR, Garassino MC, Reck M, Senan S, Naidoo J, Rimner A, Wu YL, Gray JE, Ozguroglu M, Lee KH, Cho BC, Kato T, de Wit M, Newton M, Wang L, Thiyagarajah P, Antonia SJ. Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial. J Thorac Oncol. 2021 May;16(5):860-867. doi: 10.1016/j.jtho.2020.12.015. Epub 2021 Jan 19.

    PubMed 33476803
  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surufatinib, Tislelizumab and Concurrent Chemotherapy in people with Surufatinib and Tislelizumab, 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 12 inclusion and 16 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 25 Jul 2025. 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 Bo Qiu (+862087343031, qiubo@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year progression-free survival rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07086456, which also lists 7 linked publications.

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 25 Jul 2025.

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