Neoplasms of Bone and Articular Cartilage With Unspecified Anatomical SitePhase 2NCT07619950
EVERolimus and LenvAtinib Versus Everolimus for Bone Sarcoma
A Phase 2 study testing Everolimus and Lenvatinib and Everolimus in people with Neoplasms of Bone and Articular Cartilage With Unspecified Anatomical Site, run by Yonsei University.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 79 years
- Conditions the study is for
- Neoplasms of Bone and Articular Cartilage With Unspecified Anatomical Site
- What is being tested?
- Everolimus and Lenvatinib and Everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed advanced Osteosarcoma, Ewing sarcoma, Chondrosarcoma with 1-2 prior chemotherapy
- : neoadjuvnat or adjuvant chemotherapy is counted as one regimen
- Age ≥19 years, <80 years
- ECOG performance status of 0-1
- Has at least 1 measurable lesion (as defined by Response Evaluation Criteria in Solid Tumors Version 1.1).
- Has adequate organ function defined by the following criteria:
Show all 15Show fewer
- Hb ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1000 /µL
- Platelet ≥ 75,000/ µL
- Serum Creatinine: ≥ 50 mL/min
- Total Bilirubin: ≤ 1.5 × UNL (upper normal limit)
- AST(SGOT)): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver metastasis)
- ALT(SGPT): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver metastasis)
- Female patient of childbearing potential has a negative serum or urine pregnancy test for β-hCG
- Able to provide written informed consent and comply with the protocol requirements
Who cannot join
- Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment within 2 weeks prior to entering the study. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
- Any previous treatment to lenvatinib or mTOR inhibitor
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- Major surgical procedure (as defined by the Investigator) within 14 days prior to the first dose of IP ⑤Active or prior documented autoimmune or inflammatory disorders
- -including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.
- History of the following conditions within the past 6 months.
Show all 15Show fewer
- coronary angioplasty or stent placement, myocardial infarction, unstable angina, coronary artery bypass grafting, peripheral arterial disease (Grade III) or congestive heart failure (Grade IV) according to the New York Heart Association classification, thromboembolism (patients on stable anticoagulation for ≥6 weeks are eligible), hemoptysis, intracranial hemorrhage, or clinically significant gastrointestinal bleeding ⑦Has an active infection requiring parenteral treatment
- History of another primary malignancy.
- However, enrollment is permitted in the following cases:
- Basal cell or squamous cell carcinoma of the skin after curative resection
- Cervical carcinoma in situ after at least 1 year following successful treatment
- Patients who have been disease-free for at least 3 years after completion of treatment
- ⑨Known or active CNS metastasis and/or carcinomatous meningitis
- Participants with previously treated brain metastases are eligible if radiologically stable.
- female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to emply effective birth control from screening to 90 days after the last dose
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: EVERolimus and LenvAtinib Versus Everolimus for Bone Sarcoma Progressing After Standard Treatmen : a Randomized, Phase 2, Multi-center Trial [EVERLAST]
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.
- Being tested
- Everolimus and Lenvatinib, Everolimus
- Keywords
- Everolimus, Lenvatinib, Bone Sarcoma
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus and LenvatinibDrug
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
EverolimusDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Combo | Experimental | Everolimus (5 mg) and Lenvatinib (14 mg) Receives: Drug: Everolimus and Lenvatinib |
| Mono | Active comparator | Lenvatinib (24 mg) after Everolimus (10 mg) Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free rate (PFR6)
Progression free rate (PFR-6) at 24 weeks will be based on RECIST version 1.1
Measured: up to 3 years
Secondary outcomes (3)
Progression-free survival (PFS)
The earlier of the date of first documented progressive disease or death from the date of enrollment
Measured: up to 3 years
Overall survival (OS)
From the date of treatment initiation to the date of death or last follow-up
Measured: up to 3 years
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events: Adverse events considered related to study treatment will be assessed according to CTCAE version 5.0.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms of Bone and Articular Cartilage With Unspecified Anatomical SiteStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619950
- Sponsor's protocol ID
- 4-2026-0364
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVERolimus and LenvAtinib Versus Everolimus for Bone Sarcoma Progressing After Standard Treatmen : a Randomized, Phase 2, Multi-center Trial [EVERLAST]
- ClinicalTrials.gov ID
- NCT07619950
- Acronym / sponsor ID
- 4-2026-0364
- Keywords
- Everolimus, Lenvatinib, Bone Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combo | Experimental | Drug: Everolimus and LenvatinibEverolimus (5 mg) and Lenvatinib (14 mg) |
| Mono | Active comparator | Drug: EverolimusLenvatinib (24 mg) after Everolimus (10 mg) |
Who may qualify
- Ages
- 15 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically confirmed advanced Osteosarcoma, Ewing sarcoma, Chondrosarcoma with 1-2 prior chemotherapy
- : neoadjuvnat or adjuvant chemotherapy is counted as one regimen
- Age ≥19 years, <80 years
- ECOG performance status of 0-1
- Has at least 1 measurable lesion (as defined by Response Evaluation Criteria in Solid Tumors Version 1.1).
Key exclusion criteria (15 listed)
- -including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.
- ⑨Known or active CNS metastasis and/or carcinomatous meningitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everolimus and LenvatinibEverolimus (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 | Combo |
| EverolimusEverolimus (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. | Drug | Mono |
Primary outcome
Progression free rate (PFR6)
Time frame: up to 3 years
Progression free rate (PFR-6) at 24 weeks will be based on RECIST version 1.1
3 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 3 years
Overall survival (OS)
Time frame: up to 3 years
Number of participants with treatment-related adverse events
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Everolimus and Lenvatinib and Everolimus in people with Neoplasms of Bone and Articular Cartilage With Unspecified Anatomical Site, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyo Song Kim, Professor (+82-2-2228-8123, hyosong77@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free rate (PFR6) (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.