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Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)

Randomized Phase II Trial of Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)

NCT07092514•Washington University School of Medicine

View on ClinicalTrials.gov

Summary

This open-label, randomized phase II trial evaluates the dose delivery, tolerance, and efficacy of two dosing regimens of lenvatinib among patients with radioactive iodine resistant (RAIR) differentiated thyroid cancer (DTC).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed DTC, defined as papillary, follicular, or Hurthle Cell thyroid cancer. Papillary has several sub-types such as tall-cell and columnar cell, which are all allowed.
•Patient must have incurable RAIR DTC, defined as disease not amenable to cure by surgery AND meeting one or more of the following criteria:
•* one or more sites of disease that do not take up RAI.
•* disease progression on RAI (given within the last 12 months).
•* receipt of cumulative dose of RAI of ≥ 600mCi.
•* patient declines or is ineligible for surgery and/or RAI.
•Measurable or evaluable disease per RECIST 1.1.
•No more than 1 prior line of VEGF/VEGFR targeted therapy for DTC. Examples of VEGF/VEGFR therapies include sorafenib, pazopanib, vandetinib, axitinib, sunitinib, and cabozantinib, but others exist.
•Symptomatic (defined by usual standard of care clinical criteria) or progressive disease on most recent prior treatment (ex: surgery, RAI, or TKI/targeted therapy) by RECIST 1.1 over the last 16 months.
•At least 18 years of age.
+27 more criteria

Exclusion Criteria

•Anaplastic, poorly differentiated/high-grade, and medullary thyroid cancers.
•Prior treatment with lenvatinib.
•Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
•Currently receiving any other investigational agents.
•Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression.
•A history of allergic reactions attributed to compounds of similar chemical or biologic composition to lenvatinib or other agents used in the study.
•Use of concurrent medications that have a high risk for QTc prolongation. A 7 day washout period of the high-risk medication is required prior to the first dose of Lenvatinib if a patient discontinues the high risk medication for trial enrollment.
•Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
•Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 14 days of C1D1.
•HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
+9 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

October 14, 2025

Primary Completion Date

April 17, 2029

Completion Date

October 31, 2034

Last Updated

March 17, 2026

Enrollment

ESTIMATED participants

Conditions

Thyroid CancerCancer of the Thyroid

Interventions

Lenvatinib

DRUG

Contacts

Brendan Knapp, M.D.

CONTACT

314-362-5486 bjknapp@wustl.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)

Inclusion Criteria

Exclusion Criteria

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