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

Summary

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).

Timeline

Start

2017-08-17

Primary completion

2020-02-14

Completion

2024-06-20

Outcome

Missed primary endpoint

registry analysis (non-inferiority test); Lenvatinib 14 mg + Everolimus 5 mg vs Lenvatinib 18 mg + Everolimus 5 mg; p = 0.2676; NCT03173560 ↗

registry analysis (superiority test); Lenvatinib 14 mg + Everolimus 5 mg vs Lenvatinib 18 mg + Everolimus 5 mg; p = 0.4763; NCT03173560 ↗

Publications

• Bergerot C, Young Rha S, Pal S, Koralewski P, Stroyakovskiy D, Alekseev B, Parnis F, Castellano D, Lyun Lee J, Sunela K, Ciuleanu T, Heng D, Glen H, Wang J, Bennett L, Pan J, O'Hara K, Puente J. Health-Related Quality of Life Outcomes With Two Different Starting Doses of Lenvatinib in Combination With Everolimus for Previously Treated Renal Cell Carcinoma. Oncologist. 2023 Jan 18;28(1):59-71. doi: 10.1093/oncolo/oyac142.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	5 mg	Oral
Subject	Lenvatinib	Small molecule	14 mg	Oral
Subject	Lenvatinib	Small molecule	18 mg	Oral

Indications