Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma

ClinicalTrials.gov ID: NCT03173560

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Official title

A Randomized, Open-Label (Formerly Double-Blind), Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination With Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective response rate \[ORR\] at 24 weeks \[ORR24W\]) with an improved safety profile compared to lenvatinib 18 mg in combination with everolimus 5 mg (based on treatment-emergent intolerable Grade 2, or any greater than or equal to (\>=) Grade 3 adverse events (AEs) in the first 24 weeks after randomization).

Study identification

NCT ID: NCT03173560
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Eisai Inc.; Industry
Enrollment: 343 participants

Conditions and interventions

Conditions

Renal Cell Carcinoma

Interventions

lenvatinib Drug
everolimus Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 17, 2017 (Actual)
Primary completion: Feb 14, 2020 (Actual)
Completion: Jun 20, 2024 (Actual)
Last update posted: Apr 1, 2025

2017 – 2024

United States locations

U.S. sites: 8
U.S. states: 7
U.S. cities: 8

Facility	City	State	ZIP	Site status
City of Hope National Medical Center	Duarte	California	91010	—
Innovative Clinical Research Institute, LLC	Whittier	California	90603	—
Baptist Health Medical Group Oncology, LLC - US Oncology	Miami	Florida	33143	—
Optimal Research	Honolulu	Hawaii	96819	—
Oklahoma Cancer Specialist and Research Institute , LLC	Tulsa	Oklahoma	74146	—
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	15232	—
University of Tennessee Medical Center	Knoxville	Tennessee	37920	—
Texas Oncology PA - US Oncology	Fort Worth	Texas	76104	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 85 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03173560, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 1, 2025 · Synced Nov 14, 2026