NCT05014828

To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Participants With Selected Solid Tumors

A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluated the safety and potential benefits of combining two cancer treatments, tislelizumab and lenvatinib, in Chinese participants with advanced or metastatic cancers, including lung, head and neck, bladder, kidney, and stomach cancer. The study included two parts: the first part assessed how safe the drug combination was, and the second part examined how well it worked. A small group of participants initially received the drugs to determine the appropriate dose, and if the treatment was well tolerated, additional participants were treated at that dose. Participants remained on the treatment unless their cancer progressed, they experienced serious side effects, or they chose to stop.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	lenvatinib	Administered at the dose of 20 mg orally, once daily.
DRUG	Tislelizumab	400 mg administered intravenously on Day 1 of each 42-day cycle

Timeline

• Start date: 2021-09-18
• Primary completion: 2023-10-20
• Completion: 2024-07-10
• First posted: 2021-08-20
• Last updated: 2025-08-24
• Results posted: 2025-08-24

Locations

13 sites across 1 country: China