Lenvatinib for Thyroid Cancer

Overseen By Brendan Knapp, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: QTc prolongation drugs

Disqualifiers: Anaplastic thyroid cancer, untreated brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of two different doses of lenvatinib, a medication for thyroid cancer that no longer responds to radioactive iodine treatment. The researchers aim to determine which dose works better and is easier to tolerate for people with this type of thyroid cancer. They seek participants with papillary, follicular, or Hurthle cell thyroid cancer that cannot be cured with surgery or radioactive iodine, especially if their cancer has worsened despite treatment. As a Phase 2 trial, this research focuses on measuring how well the treatment works in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial requires a 7-day period without taking any medications that have a high risk for QTc prolongation (a heart rhythm issue) before starting lenvatinib. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that lenvatinib is likely to be safe for humans?

Research has shown that lenvatinib can be safe for people with thyroid cancer, but some risks exist. In one study, 48.1% of patients stopped taking lenvatinib due to unwanted side effects. One person developed a serious condition called posterior reversible encephalopathy syndrome. Despite this, lenvatinib generally maintains a good safety record. It works well for both men and women and can help patients live longer without their cancer worsening.

Lenvatinib is already approved for treating thyroid cancer, indicating it is usually well-tolerated. However, individual experiences can vary, and some people might experience significant side effects. It's important to consult healthcare providers to understand the risks and benefits before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for thyroid cancer?

Lenvatinib is unique because it targets specific proteins involved in the growth of thyroid cancer cells, offering a more precise approach than traditional treatments like surgery or radioactive iodine. Unlike most treatments that focus generally on cancer cell elimination, Lenvatinib inhibits the pathways that supply blood to the tumor, potentially slowing its growth more effectively. Researchers are particularly interested in the different dosages being tested—10 mg/day and 24 mg/day—since finding the optimal dose could maximize benefits while minimizing side effects. This targeted approach and the exploration of dosing are what make Lenvatinib stand out in the treatment of thyroid cancer.

What evidence suggests that lenvatinib might be an effective treatment for thyroid cancer?

Studies have shown that lenvatinib effectively treats thyroid cancer unresponsive to radioactive iodine. Research indicates that lenvatinib can extend the time patients live without cancer progression to about 18.7 months. Another study found that patients experienced 35.2 months without cancer progression and lived for a total of 56.2 months on average. In this trial, participants will receive either 10 mg/day or 24 mg/day of lenvatinib. These findings suggest that lenvatinib can significantly slow the spread of thyroid cancer, providing patients with more time without disease worsening. ^{3 6 7 8 9}

Who Is on the Research Team?

Brendan Knapp, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with differentiated thyroid cancer that's resistant to radioactive iodine treatment. Participants must have a confirmed diagnosis, disease progression after RAI therapy within the last year, and no more than one prior VEGF/VEGFR targeted therapy. They should be symptomatic or show disease progression and not be candidates for surgery or additional RAI.

Inclusion Criteria

My cancer can be measured or evaluated by standard criteria.

I am 18 years old or older.

I have cancer that does not respond to radioactive iodine treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lenvatinib at either 10 mg/day or 24 mg/day. Each cycle is 28 days.

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lenvatinib

Trial Overview The study is testing two different doses of lenvatinib (24 mg/day vs. 10 mg/day) in patients with RAIR differentiated thyroid cancer to see which dose is better tolerated and more effective.

How Is the Trial Designed?

Group I: Arm 2: Lenvatinib 24 mg/day Experimental Treatment 1 Intervention

Lenvatinib 24 mg per day. Each cycle is 28 days.

Group II: Arm 1: Lenvatinib 10 mg/day Active Control 1 Intervention

Lenvatinib 10 mg per day. Each cycle is 28 days.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12293624/

Therapeutic Efficacy of a Very Low/Low Dose of Lenvatinib ... Lenvatinib is a multi-kinase inhibitor that has demonstrated notable efficacy in extending the median progression-free survival (PFS) for ...

2. etj.bioscientifica.com etj.bioscientifica.com/view/journals/etj/12/2/ETJ-23-0003.xml

Outcomes of lenvatinib therapy in poorly differentiated thyroid ... Survival rates range between 50–85, 34–50, and 0% at 5, 10, and 15 years after diagnosis, respectively (1, 4, 5). Higher mortality rates have been associated ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e18104

Clinical outcomes in patients with radioiodine refractory ... Median progression free survival and overall survival were 35.2 months and 56.2 months, respectively. Eighteen patients remain on therapy.

4. nature.com nature.com/articles/s44276-025-00153-2

Real-world treatment outcomes and clinicopathologic ... Our findings reinforce the clinical efficacy of lenvatinib in advanced thyroid cancer patients with heterogenous clinicopathologic/molecular features.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1406470

Lenvatinib versus Placebo in Radioiodine-Refractory ... The median progression-free survival with lenvatinib was 18.7 months among patients who had not received previous treatment with a tyrosine ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9032633/

Lenvatinib Therapy for Advanced Thyroid Cancer Lenvatinib was discontinued due to AEs in 13/27 patients (48.1%). Interestingly, 1 patient experienced a grade 4 posterior reversible encephalopathy syndrome, ...

7. ejcancer.com ejcancer.com/article/S0959-8049(19)30358-2/abstract

Real-world efficacy and safety of lenvatinib Lenvatinib is active and safe, even in a real-life patient population. •. Older patients show survival benefit from lenvatinib, without safety ...

8. etj.bioscientifica.com etj.bioscientifica.com/view/journals/etj/14/2/ETJ-24-0386.xml

Gender impact on safety and efficacy in lenvatinib treated ... Lenvatinib is effective in both sexes and exhibits a good safety profile, with a sex difference in the frequencies of some adverse events.

9. lenvimahcp.com lenvimahcp.com/rai-refractory-differentiated-thyroid-cancer/real-world-evidence

A real-world study of LENVIMA® (lenvatinib) in RAI-R ... See real-world evidence on LENVIMA® (lenvatinib) in RAI-refractory differentiated thyroid cancer in this study presented at the American Thyroid Association ...