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New combo therapy could shrink rare lung tumors

NCT ID NCT07357623

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding chemotherapy to surufatinib works better than surufatinib alone for people with a rare lung cancer called pulmonary neuroendocrine tumor. About 96 adults will be randomly assigned to one of two treatment groups. The goal is to see if the combination shrinks tumors more and helps people live longer, while checking for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Have a full understanding of this study and voluntarily sign the informed consent form; 2. 18-75 years old (including cut-off value), male or female; 3. Patients must have at least one measurable lesion (RECIST 1.1); 4. Histologically or cytologically confirmed pulmonary neuroendocrine tumor (typical or atypical carcinoid) \[at least one neuroendocrine immunohistochemistry marker (CD56, CgA, Syn) definitively positive on the basis of morphological features of neuroendocrine tumors\]; 5. 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); 6. ECOG PS 0-1 (PS 0-2 for amputees); 7. Expected survival ≥ 12 weeks; 8. 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); 9. 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.). Exclusion Criteria: 1. Patients who have received surufatinib or other anti-angiogenic drugs in the past; 2. Received approved or investigational systemic anti-tumor therapy within 4 weeks before enrollment, including: chemotherapy, any form of radiotherapy, biological immunotherapy, targeted therapy, etc.; 3. 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; 4. 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.); 5. International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \>1.5× ULN; 6. Clinically significant electrolyte abnormalities judged by the investigator; 7. Presence of hypertension that cannot be controlled by medication, as prescribed as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg; 8. Patient currently has any disease or condition that affects drug absorption, or patient cannot take surufatinib orally; 9. 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; 10. 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; 11. 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%; 12. 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; 13. 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;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking Union Medical College Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100000, China

  • Shanghai chest hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • The First Affiliated Hospital Of Anhui Medical University

    NOT_YET_RECRUITING

    Hefei, Anhui, 230000, China

  • The First Affiliated Hospital of Zhengzhou University

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450000, China

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