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Can adding lenvatinib to standard care outsmart a tough brain cancer?

NCT ID NCT07754734

Disease control Sponsor: Dongguan People's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This phase II trial is asking whether adding the drug lenvatinib to the standard STUPP regimen (temozolomide plus radiation) can improve outcomes for people newly diagnosed with a type of brain cancer called glioblastoma that has a specific genetic marker (MGMT promoter methylation). About 138 adults aged 18-75 will be randomly assigned to receive either the standard regimen alone or the standard regimen plus lenvatinib. The study will track how long participants live without the cancer progressing, overall survival, and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lenvatinib combined with temozolomide and radiotherapy (the STUPP regimen)
What this could lead to
If adding lenvatinib to the standard STUPP regimen slows tumor growth, it could offer a new first-line treatment option for a subset of glioblastoma patients.
What could go wrong
This is an early-phase trial, so the benefit is unproven. Lenvatinib may add side effects without improving survival, and results may not apply to all glioblastoma patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 138 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Newly diagnosed GBM confirmed by post-op pathology/biopsy, MGMT promoter methylation positive, no prior RT or chemo. * Surgery/biopsy ≤ 21 days before enrollment. * Age 18-75 years any gender. * KPS ≥ 70. * Organ function (no blood components or growth factors within 14 days): 1. ANC ≥ 1.5 × 10⁹/L; PLT ≥ 100 × 10⁹/L; Hb ≥ 90 g/L. 2. Total bilirubin ≤ 1.5 × ULN. 3. ALT, AST ≤ 3 × ULN. 4. Serum creatinine ≤ 1.5 × ULN or CrCl ≥ 50 mL/min. * Life expectancy ≥ 12 weeks. * Stable or tapering corticosteroid dose for 14 days. * Voluntary participation, signed informed consent, and good compliance. Exclusion Criteria: * Allergy to Lenvatinib, TMZ, or components. * Other malignancies within 5 years or concurrent, or prior anti-tumor therapy. * Concurrent participation in another clinical trial (except observational). * Comorbidities interfering with treatment: 1. Grade 4 non-hematological toxicity (except hair loss, nausea, vomiting). 2. Conditions interfering with oral drugs (dysphagia, chronic diarrhea, bowel obstruction). * Evidence of increased intracranial pressure (midline shift \> 5 mm, papilledema, vomiting, decreased consciousness). * History of drug/alcohol abuse. * Pregnancy or lactation. * Other conditions judged by the investigator (e.g., unstable heart/kidney disease, uncontrolled diabetes, mood disorders).

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Conditions

The condition(s) this trial relates to.

glioblastoma glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glioblastoma (GBM) GLIOMA MGMT-methylated glioblastoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.