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NOT YET RECRUITING
NCT07619950
PHASE2

EVERolimus and LenvAtinib Versus Everolimus for Bone Sarcoma

Sponsor: Yonsei University

View on ClinicalTrials.gov

Summary

Those studies demonstrate strong rationale to combine a multikinase inhibitor targeting VEGFR, PDGFR with mTOR inhibitor. Moreover, another multi-targeted TKI, lenvatinib monotherapy showed promising activity in osteosarcoma. Therefore, clinical trial with Lenvatinib in combined with everolimus is ongoing for solid tumors (NCT03245151). Considering lenvatinib and everolimus (18 mg/day and 5 mg/day) already approved as standard treatment for renal cell carcinoma based on the powerful ORR, PFS, and OS14, these noteworthy findings advance the treatment paradigm for bone sarcoma patients. Because all those trials for sarcoma were done in the absence of a control group, based on such clinical studies, a confirmatory trial comparing mTOR inhibitor and a multi-targeted tyrosine kinase inhibitor (multi-TKI) combination versus monotherapy is essential. Therefore, we planned to conduct the randomized phase II trial of everolimus in combination with lenvatinib for advanced/metastatic bone sarcomas. In addition, we will explore predictive biomarkers by repeated biopsies and blood samplings during the treatment.

Official title: EVERolimus and LenvAtinib Versus Everolimus for Bone Sarcoma Progressing After Standard Treatmen : a Randomized, Phase 2, Multi-center Trial [EVERLAST]

Key Details

Gender

All

Age Range

15 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2026-07-01

Completion Date

2028-11-30

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

DRUG

Everolimus and Lenvatinib

Everolimus (5 mg) and Lenvatinib (14 mg) will be administered orally once daily (QD) in continuous 28-day cycles. In subjects who maintain toxicity at Grade ≤2 during the initial 4-week period (Cycle 1), the Lenvatinib dose may be escalated to 18 mg QD beginning in Cycle 2, at the discretion of the investigator

DRUG

Everolimus

Everolimus (10 mg) will be administered orally once daily (QD) as monotherapy in continuous 28-day cycles. Upon radiologic or clinical disease progression, subjects may switch to Lenvatinib (24 mg) monotherapy, administered orally once daily (QD) in 28-day cycles.