A Single-arm, Multicenter, Phase 2 Study of Lenvatinib Plus Everolimus in Patients with Advanced Non-Clear Cell Renal Cell Carcinoma.

ABSTRACT:

Background

Non-clear cell renal cell carcinoma (nccRCC) accounts for ≤20% of RCC cases. Lenvatinib (a multitargeted tyrosine kinase inhibitor) in combination with everolimus (an mTOR inhibitor) is approved for the treatment of advanced RCC after one prior antiangiogenic therapy.

Objective

To determine the safety and efficacy of lenvatinib plus everolimus as a first-line treatment for patients with advanced nccRCC.

Design, setting, and participants

This open-label, single-arm, multicenter, phase 2 study enrolled patients with unresectable advanced or metastatic nccRCC and no prior anticancer therapy for advanced disease.

Intervention

Lenvatinib (18 mg) plus everolimus (5 mg) orally once daily.

Outcome measurements and statistical analysis

The primary endp

SUBMITTER: Hutson TE 

PROVIDER: S-EPMC12684810 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature