drugset / Trial / NCT07357623

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

NCT07357623

Phase 2 Recruiting 96 enrolled Shanghai Chest Hospital
RandomizedParallel-groupOpen-labelTreatment

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 Treatment will continued until disease progression, death, intolerable toxicity, or withdrawn.

Timeline

Start
2025-09-22
Primary completion
2027-09-01
Completion
2028-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 75 mg/m2 Oral
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Etoposide Small molecule 100 mg/m2 Intravenous
Subject Surufatinib Small molecule 250 mg Oral
Subject Surufatinib Small molecule 300 mg Oral
Subject Temozolomide Small molecule 150 mg/m2 Oral
Subject Temozolomide Small molecule 200 mg/m2 Oral