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Thyroid CancerPhase 2NCT07092514

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

A Phase 2 study testing Lenvatinib in people with Thyroid Cancer and Cancer of the Thyroid, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer, Cancer of the Thyroid
What is being tested?
Lenvatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
14 Oct 2025to 31 Oct 2034
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • ECOG performance status ≤ 2.
  • Screening blood pressure measurement <140/90. Retesting is allowed.
  • Adequate bone marrow and organ function as defined below:
  • Absolute neutrophil count ≥ 1.0 K/cumm
  • Platelets ≥ 100 K/cumm
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5 x IULN
  • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN (5.0 x IULN in the presence of hepatic metastases)
  • Creatinine clearance > 30 mL/min by Cockcroft-Gault
  • UPC ≤ 1000 mg/G
  • QTcF < 481 msec
  • The effects of lenvatinib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose of lenvatinib. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
  • Measurable or evaluable disease per RECIST 1.1.
  • Symptomatic (defined by usual standard of care clinical criteria) or progressive disease by RECIST 1.1 while on lenvatinib.
  • ECOG performance status ≤ 2.
  • Re-screening blood pressure measurement <140/90.
  • Adequate bone marrow and organ function as defined below:
  • Absolute neutrophil count ≥ 1.0 K/cumm
  • Platelets ≥ 100 K/cumm
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5 x IULN
  • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN (5.0 x IULN in the presence of hepatic metastases)
  • Creatinine clearance > 30 mL/min by Cockcroft-Gault
  • UPC ≤ 1000 mg/G
  • QTcF < 481 msec
  • The most recent dose level of lenvatinib must be 10 mg/day.

Who cannot join

  • 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.
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  • 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.
  • Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
  • History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
  • Major surgery ≤ 14 days prior to C1D1; any surgical wound must be fully healed prior to C1D1.
  • Currently receiving any other investigational agents.
  • Patients with untreated brain metastases. Patients with treated brain metastases (including those who had intracranial progression while on Lenvatinib) are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression.
  • Use of concurrent medications that have a high risk for QTc prolongation.
  • 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.
  • Experienced a grade three or higher treatment related adverse event requiring a dose delay on the 10 mg/day lenvatinib cohort
  • Pregnant and/or breastfeeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brendan Knapp, M.D. contact

314-362-5486

bjknapp@wustl.edu

United States1 site, 1 recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Brendan Knapp, M.D., 314-362-5485, bjknapp@wustl.edu

    Brendan Knapp, M.D.

    Recruiting

Other trials in United States

About this study

Official title: 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)

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).

Being tested
Lenvatinib
Keywords
Lenvatinib, Radioactive iodine resistant, Thyroid cancer
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenvatinibDrug

    Also called Lenvima

    Lenvatinib is an oral drug which will be administered on an outpatient basis at a dose of 24 mg daily or 10 mg daily for an unlimited number of cycles.

Study groups in NCT07092514
Study groupRoleWhat they receive
Arm 1: Lenvatinib 10 mg/dayActive comparatorLenvatinib 10 mg per day. Each cycle is 28 days.
Receives: Drug: Lenvatinib
Arm 2: Lenvatinib 24 mg/dayExperimentalLenvatinib 24 mg per day. Each cycle is 28 days.
Receives: Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of requiring a dose reduction of lenvatinib due to adverse event

    Measured: First 24 weeks of therapy

Secondary outcomes (6)

  1. Progression-free survival (PFS)

    Measured: Through completion of follow-up (estimated to be 6 years)

  2. Incidence rate of requiring a dose interruption or delay of lenvatinib due to adverse event

    Measured: First 24 weeks of therapy

  3. Incidence rate of requiring discontinuation of lenvatinib due to adverse event

    Measured: First 24 weeks of therapy

  4. Daily dose intensity of lenvatinib

    Measured: First 24 weeks of therapy

  5. Number of patients with adverse events

    Measured: From start of treatment through 28 days after last dose of lenvatinib (estimated to be 13 months)

  6. Tumor response rate

    Measured: First 12 months of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start14 Oct 2025
  3. Primary completion17 Apr 2029 (estimated)
  4. Study completion31 Oct 2034 (estimated)

Resources

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
Crossover
Model description
Patients on Arm 1 can crossover to Arm 2 at the time of progression
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07092514
Sponsor's protocol ID
202508169
Status last verified
Mar 2026
First submitted
21 Jul 2025
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), and the study protocol will be shared, beginning 9 months and ending 24 months following article publication, with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Types of acceptable analyses include approved proposal(s) or individual participant data for meta-analyses.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib in people with Thyroid Cancer and Cancer of the Thyroid, run by Washington University School of Medicine at 1 site in United States.

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 37 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Brendan Knapp, M.D. (314-362-5486, bjknapp@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of requiring a dose reduction of lenvatinib due to adverse event (time frame: First 24 weeks of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07092514.

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 17 Mar 2026.

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