Pulmonary Neuroendocrine TumorPhase 2NCT07357623
Surufatinib Combined With Chemo Versus Surufatinib in the Treatment of Pulmonary Neuroendocrine Tumors
A Phase 2 study testing Surufatinib Combined With Standard chemotherapy and Surufatinib in people with Pulmonary Neuroendocrine Tumor, run by Shanghai Chest Hospital at 4 sites in China.
Trial summary
The goal of this clinical trial is to investigate if chemotherapy works with surufatinib to treat pulmonary neuroendocrine tumors. It will also learn about the safety of this combination regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Neuroendocrine Tumor
- What is being tested?
- Surufatinib Combined With Standard chemotherapy and Surufatinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 4 sitesChina
- Study dates
- 22 Sep 2025to 1 Sep 2028
- 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
- Have a full understanding of this study and voluntarily sign the informed consent form;
- 18-75 years old (including cut-off value), male or female;
- Patients must have at least one measurable lesion (RECIST 1.1);
- Histologically or cytologically confirmed pulmonary neuroendocrine tumor (typical or atypical carcinoid) [at least one neuroendocrine immunohistochemistry marker (CD56, CgA, Syn) definitively positive on the basis of morphological features of neuroendocrine tumors];
- Patients who have not received systemic therapy in the past (Note: neoadjuvant or adjuvant chemotherapy is allowed in the early stage, and if disease progression/recurrence occurs ≥ 6 months after the end of neoadjuvant/adjuvant last therapy, it can also be included);
- ECOG PS 0-1 (PS 0-2 for amputees);
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- Expected survival ≥ 12 weeks;
- Blood test (without blood transfusion within 14 days) 1) Absolute neutrophil value ≥1.5×109/L, platelet ≥ 100×109/L, hemoglobin ≥9g/dL; 2) Liver function tests (AST and ALT≤2.5×ULN, total bilirubin≤1.5×ULN; AST and ALT ≤5×ULN) if liver metastases are present; 3) Renal function (serum creatinine ≤1.5×ULN, creatinine clearance (CCr) ≥60ml/min);
- Male or female patients of childbearing potential voluntarily use effective contraceptive methods, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. during the study and within 6 months of the last study medication. All female patients will be considered of childbearing potential unless the female patient is naturally postmenopausal, has undergone artificial menopause, or has undergone sterilization (e.g., hysterectomy, bilateral adnextomy, or radioactive ovarian irradiation, etc.).
Who cannot join
- Patients who have received surufatinib or other anti-angiogenic drugs in the past;
- Received approved or investigational systemic anti-tumor therapy within 4 weeks before enrollment, including: chemotherapy, any form of radiotherapy, biological immunotherapy, targeted therapy, etc.;
- Participated in other domestic drug clinical trials that have not been approved or marketed within 4 weeks before enrollment and received corresponding trial drug treatment;
- Undergoing any surgery or invasive treatment or operation within 4 weeks before enrollment that affects wound healing (except for intravenous catheterization, puncture and drainage, etc.);
- International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) >1.5× ULN;
- Clinically significant electrolyte abnormalities judged by the investigator;
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- Presence of hypertension that cannot be controlled by medication, as prescribed as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
- Patient currently has any disease or condition that affects drug absorption, or patient cannot take surufatinib orally;
- Patients currently have active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigator;
- Patients with obvious evidence or history of bleeding tendency within 3 months prior to enrollment (bleeding >30 mL within 3 months, hematemesis, black feces, blood in the stool), hemoptysis (>5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months;
- Significant clinically significant cardiovascular disease, including but not limited to the following: acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure New York Heart Association (NYHA) grade >2; ventricular arrhythmias requiring medication; LVEF (left ventricular ejection fraction) < 50%;
- Other malignant tumors within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
- Active or uncontrolled serious infection:
- 1) Known human immunodeficiency virus (HIV) infection; 2) Known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must rule out active HBV infection, i.e., HBV DNA positive (>1×104 copies/mL or >2000 IU/ml); 3) Known hepatitis C virus infection (HCV) with positive HCV RNA (>1×103 copies/mL), or other hepatitis, cirrhosis; 14. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects who have been previously treated for brain metastases may be enrolled provided that the patient's disease is clinically stable for at least 2 weeks and there is no evidence of new or enlarging brain metastases and steroids are off 3 days prior to administration of study drug. According to this definition, stable brain metastases should be determined prior to the first dose of study drug. Subjects with asymptomatic brain metastases (i.e., no neurological symptoms, no need for corticosteroids, and no lesions >1.5 cm) may be enrolled, but require regular imaging of the brain as a site of disease; 15. Patients with persistent toxicity caused by any previous anti-tumor therapy that has not recovered to grade ≤2, but have any grade of alopecia and lymphopenia are allowed to participate in this study; 16. Pregnant (positive pregnancy test before medication) or breastfeeding; 17. Received blood transfusion therapy, blood products and hematopoietic factors such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment; 18. The investigator believes that the subject has any clinical or laboratory abnormalities or other reasons that are not suitable for participation in this clinical study; 19. Those who showed urine protein ≥ 2 and had a quantitative of > 1.0g in 24 hours;
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Yuejuan Cheng, Phd, 010-69159883, chengyuejuan@pumch.cn
- Not yet recruiting
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, 230000
Kangsheng Gu, Phd, (0551)63633742, Kangshenggu@126.com
- Recruiting
Shanghai chest hospital
Shanghai, Shanghai Municipality, 200000
Baohui Han, Phd, 021-22200000, hanbaohui@csco.org.cn
Baohui Han, Phd
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Lijie Song, Phd, 0371-66913114, lijiesongcn@hotmail.com
About this study
Official title: Surufatinib Plus Standard Chemotherapy Versus Surufatinib Monotherapy in Patients With Pulmonary Neuroendocrine Tumors: a Randomized, Controlled, Open-label Study
The goal of this clinical trial is to investigate if chemotherapy works with surufatinib to treat pulmonary neuroendocrine tumors. It will also learn about the safety of this combination regimen. The main questions it aims to answer are:
Does chemotherapy combined with surufatinib could bring more survival benefits (ie. higher response rate or longer survival time) for patients with pulmonary neuroendocrine tumors? Is this combination regimen safe?
Read more
Researchers will compare chemotherapy plus surufatinib with surufatinib monotherapy to see if this combination regimen works to treat pulmonary neuroendocrine tumors.
Participants will:
Take chemotherapy(Etoposide+Carboplatin, EC or Capecitabine+Temozolomide, CAPTEM) plus surufatinib or surufatinib monotherapy every 3 or 4 weeks as a cycle.
Visit the clinic once every cycle for checkups and tests. Tumor assessment is performed every 2 cycles. Treatment will continued until disease progression, death, intolerable toxicity, or withdrawn.
- Conditions
- Pulmonary Neuroendocrine Tumor
- Being tested
- Surufatinib Combined With Standard chemotherapy, Surufatinib
- Keywords
- surufatinib, NET, Typical carcinoid, Atypical carcinoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surufatinib Combined With Standard chemotherapyDrug
Surufatinib: 250mg , qd, po, Q4W Capecitabine: 75mg/m2, bid, po, D1-D14, Q4w Temozolomide: 150mg-200mg/m2, qd, po, D10-D14, Q4W or Surufatinib: 250mg , qd, po, Q3W Etoposide: 100mg/m2, IV, D1-D3, Q3W Carboplatin: AUC=5, IV, D1, Q3W
SurufatinibDrug
Surufatinib: 300mg, qd, po
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib Combined With Standard chemotherapy | Experimental | Standard chemotherapy included either Capecitabine combined with Temozolomide or Etoposide plus Carboplatin Receives: Drug: Surufatinib Combined With Standard chemotherapy |
| Surufatinib | Active comparator | Not described Receives: Drug: Surufatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)(RECIST1.1)
The incidence of confirmed complete response or partial response
Measured: From date of enrollment to the end of treatment, an average of 1.5 years
Secondary outcomes (4)
Disease control rate (DCR)(RECIST1.1)
Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
Measured: From date of enrollment to the end of treatment, an average of 1.5 years
Progression-free Survival (PFS) (RECIST1.1)
A duration from the date of randomization to disease progression or death of any cause.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall Survival (OS)
Duration from the date of randomization to the date of death due to any cause
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
4-month PFS rate
Proportion of patients who did not develop disease progression (or death from any cause) at 4 months from the date of randomization
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start22 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Model description
- 1:1 Randomized
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baohui Han, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357623
- Sponsor's protocol ID
- HMPL-012-SPRING-NEN113
- Status last verified
- Jan 2026
- First submitted
- 7 Aug 2025
- Last updated
- 22 Jan 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surufatinib Plus Standard Chemotherapy Versus Surufatinib Monotherapy in Patients With Pulmonary Neuroendocrine Tumors: a Randomized, Controlled, Open-label Study
- ClinicalTrials.gov ID
- NCT07357623
- Acronym / sponsor ID
- HMPL-012-SPRING-NEN113
- Conditions
- Pulmonary Neuroendocrine Tumor
- Keywords
- surufatinib, NET, Typical carcinoid, Atypical carcinoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 22 Jan 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.
The goal of this clinical trial is to investigate if chemotherapy works with surufatinib to treat pulmonary neuroendocrine tumors. It will also learn about the safety of this combination regimen. The main questions it aims to answer are:
Does chemotherapy combined with surufatinib could bring more survival benefits (ie. higher response rate or longer survival time) for patients with pulmonary neuroendocrine tumors? Is this combination regimen safe?
Researchers will compare chemotherapy plus surufatinib with surufatinib monotherapy to see if this combination regimen works to treat pulmonary neuroendocrine tumors.
Participants will:
Take chemotherapy(Etoposide+Carboplatin, EC or Capecitabine+Temozolomide, CAPTEM) plus surufatinib or surufatinib monotherapy every 3 or 4 weeks as a cycle.
Visit the clinic once every cycle for checkups and tests. Tumor assessment is performed every 2 cycles. Treatment will continued until disease progression, death, intolerable toxicity, or withdrawn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 Randomized
| Arm | Type | Receives |
|---|---|---|
| Surufatinib Combined With Standard chemotherapy | Experimental | Drug: Surufatinib Combined With Standard chemotherapyStandard chemotherapy included either Capecitabine combined with Temozolomide or Etoposide plus Carboplatin |
| Surufatinib | Active comparator | Drug: Surufatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have a full understanding of this study and voluntarily sign the informed consent form;
- 18-75 years old (including cut-off value), male or female;
- Patients must have at least one measurable lesion (RECIST 1.1);
- Histologically or cytologically confirmed pulmonary neuroendocrine tumor (typical or atypical carcinoid) [at least one neuroendocrine immunohistochemistry marker (CD56, CgA, Syn) definitively positive on the basis of morphological features of neuroendocrine tumors];
- Patients who have not received systemic therapy in the past (Note: neoadjuvant or adjuvant chemotherapy is allowed in the early stage, and if disease progression/recurrence occurs ≥ 6 months after the end of neoadjuvant/adjuvant last therapy, it can also be included);
Key exclusion criteria (14 listed)
- Patients who have received surufatinib or other anti-angiogenic drugs in the past;
- Received approved or investigational systemic anti-tumor therapy within 4 weeks before enrollment, including: chemotherapy, any form of radiotherapy, biological immunotherapy, targeted therapy, etc.;
- Participated in other domestic drug clinical trials that have not been approved or marketed within 4 weeks before enrollment and received corresponding trial drug treatment;
- Undergoing any surgery or invasive treatment or operation within 4 weeks before enrollment that affects wound healing (except for intravenous catheterization, puncture and drainage, etc.);
- International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) >1.5× ULN;
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 |
|---|---|---|
| Surufatinib Combined With Standard chemotherapySurufatinib: 250mg , qd, po, Q4W Capecitabine: 75mg/m2, bid, po, D1-D14, Q4w Temozolomide: 150mg-200mg/m2, qd, po, D10-D14, Q4W or Surufatinib: 250mg , qd, po, Q3W Etoposide: 100mg/m2, IV, D1-D3, Q3W Carboplatin: AUC=5, IV, D1, Q3W | Drug | Surufatinib Combined With Standard chemotherapy |
| SurufatinibSurufatinib: 300mg, qd, po | Drug | Surufatinib |
Primary outcome
Objective response rate (ORR)(RECIST1.1)
Time frame: From date of enrollment to the end of treatment, an average of 1.5 years
The incidence of confirmed complete response or partial response
4 secondary outcomes
Disease control rate (DCR)(RECIST1.1)
Time frame: From date of enrollment to the end of treatment, an average of 1.5 years
Progression-free Survival (PFS) (RECIST1.1)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall Survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
4-month PFS rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 months
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 22 Jan 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surufatinib Combined With Standard chemotherapy and Surufatinib in people with Pulmonary Neuroendocrine Tumor, run by Shanghai Chest Hospital at 4 sites 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 9 inclusion and 14 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Baohui Han, Phd (021-22200000, hanbaohui@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR)(RECIST1.1) (time frame: From date of enrollment to the end of treatment, an average of 1.5 years). 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 22 Jan 2026.