drugset / Trial / NCT07165418

A Comparison of Vorolanib Tablets Combined With Everolimus Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma Who Have Progressed After Treatment With Immunotherapy Monotherapy or in Combination With TKI

NCT07165418

Phase 3 Not yet recruiting 116 enrolled Peking University Cancer Hospital & Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a multicenter, open-label, randomized controlled trial that enrolled 116 patients with advanced or metastatic renal cell carcinoma who had failed first-line treatment with PD-1/PD-L1 monotherapy or VEGFR TKI combined with PD-1/PD-L1 therapy. Patients were randomly assigned in a 1:1 ratio to receive either the experimental group treatment with vorolanib tablets combined with everolimus or the control group treatment with sunitinib as second-line therapy until disease progression. The study aimed to evaluate the efficacy and safety of vorolanib tablets combined with everolimus as second-line therapy for renal cell carcinoma patients.

Timeline

Start
2025-09-25
Primary completion
2028-12-30
Completion
2029-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject CM082 Unknown 200 mg Oral
Subject Everolimus Small molecule 5 mg Oral
Comparator Sunitinib Small molecule 50 mg Oral

Indications