RecruitingPhase 2NCT07357623

Surufatinib Combined With Chemo Versus Surufatinib in the Treatment of Pulmonary Neuroendocrine Tumors

Surufatinib Plus Standard Chemotherapy Versus Surufatinib Monotherapy in Patients With Pulmonary Neuroendocrine Tumors: a Randomized, Controlled, Open-label Study


Sponsor

Shanghai Chest Hospital

Enrollment

96 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

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. 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 Treatment will continued until disease progression, death, intolerable toxicity, or withdrawn.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches for treating a rare type of lung cancer called a pulmonary neuroendocrine tumor (carcinoid tumor): a targeted drug called surufatinib used alone, versus surufatinib combined with chemotherapy. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with a typical or atypical carcinoid tumor of the lung, confirmed by biopsy - Your cancer is measurable on scans - You have not previously received systemic (whole-body) treatment for this cancer, or you had early-stage treatment that ended at least 6 months before relapse - You are well enough to carry out daily activities (ECOG 0–1) **You may NOT be eligible if...** - You have previously received surufatinib or other anti-angiogenic (blood vessel-targeting) drugs - You have uncontrolled high blood pressure - You have had a heart attack, stroke, or significant heart failure in the past 6 months - You have active hepatitis B, hepatitis C, HIV, or cirrhosis - You have active brain metastases - You are pregnant or breastfeeding - You have had significant bleeding in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSurufatinib Combined With Standard chemotherapy

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

DRUGSurufatinib

Surufatinib: 300mg, qd, po


Locations(4)

The First Affiliated Hospital Of Anhui Medical University

Hefei, Anhui, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Shanghai chest hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07357623


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