GliomaPhase 2NCT07754734
STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation
A Phase 2 study testing Lenvatinib, TMZ (Temozolomide) and radiotherapy in people with Glioma and Glioblastoma (GBM), run by Dongguan People's Hospital.
Trial summary
To compare the efficacy and safety of Lenvatinib combined with the standard Stupp regimen versus the standard Stupp regimen alone in the treatment of newly diagnosed glioblastoma with MGMT promoter methylation positive. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioma, Glioblastoma (GBM), MGMT-Methylated Glioblastoma
- What is being tested?
- Lenvatinib, TMZ (Temozolomide) and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2026to 31 Jul 2029
- Phase
- Phase 2
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- ANC ≥ 1.5 × 10⁹/L; PLT ≥ 100 × 10⁹/L; Hb ≥ 90 g/L.
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- Total bilirubin ≤ 1.5 × ULN.
- ALT, AST ≤ 3 × ULN.
- 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.
Who cannot join
- 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:
- Grade 4 non-hematological toxicity (except hair loss, nausea, vomiting).
- Conditions interfering with oral drugs (dysphagia, chronic diarrhea, bowel obstruction).
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- 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).
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: STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation: A Multicenter, Randomized Phase II Clinical Trial
To compare the efficacy and safety of Lenvatinib combined with the standard Stupp regimen versus the standard Stupp regimen alone in the treatment of newly diagnosed glioblastoma with MGMT promoter methylation positive.
- Conditions
- Glioma, Glioblastoma (GBM), MGMT-Methylated Glioblastoma
- Being tested
- Lenvatinib, TMZ (Temozolomide), radiotherapy
- Keywords
- Stupp regimen, Lenvatinib, phase II clinical trial, glioblastoma and MGMT promoter methylation
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Chemotherapy:Lenvatinib-TMZ Group: During RT, TMZ 75 mg/m² po QD and Lenvatinib 20 mg po QD; 4 weeks after RT, 6 cycles of TMZ maintenance; Lenvatinib continues at 20 mg QD post-RT until progression or intolerable toxicity.
TMZ (Temozolomide)Drug
Chemotherapy: TMZ Group: During RT, TMZ 75 mg/m² po QD; 4 weeks after RT, 6 cycles
radiotherapyRadiation
Starts 2-6 weeks post-op; total dose 60 Gy (2.0 Gy/fraction, 30 fractions) over 6-7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| experimental group：Lenvatinib + TMZ + radiotherapy | Experimental | Lenvatinib + TMZ + radiotherapy：During RT, TMZ 75 mg/m² po QD and Lenvatinib 20 mg po QD; 4 weeks after RT, 6 cycles of TMZ maintenance; Lenvatinib continues at 20 mg QD post-RT until progression or intolerable toxicity. Receives: Drug: Lenvatinib; Drug: TMZ (Temozolomide); Radiation: radiotherapy |
| control group：TMZ + radiotherapy | Active comparator | TMZ + radiotherapy：During RT, TMZ 75 mg/m² po QD; 4 weeks after RT, 6 cycles of TMZ (150-200 mg/m² po D1-D5, Q4W) maintenance. Receives: Drug: TMZ (Temozolomide); Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival（PFS）
defined as the time from enrollment to the first documented local-regional recurrence, distant metastasis, or death from any cause
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcomes (5)
Overall survival (OS)
defined as the time from enrollment to death from any cause.
Measured: From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 36 months
Best Overall Response (BOR)
determined by modified RANO criteria for patients with incomplete tumor resection and documented postoperative residual tumor.
Measured: 36 months
Safety evaluation
Adverse events (AE) and serious adverse events (SAE) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE V5.0).
Measured: During the concurrent chemoradiotherapy phase; Weekly during maintenance chemotherapy cycles 1-6 (the worst result within each cycle will be recorded); At the end of treatment or disease progression. whichever came first, assessed up to 36 months.
Function quality of Life
Aassessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 ( (EORTC QLQ-C30) : Scores are converted to 0-100 scale. Higher scores indicate better functioning and quality of life for functional and global health/QoL domains, while higher symptom scores indicate greater symptom burden.
Measured: Before the concurrent chemoradiotherapy phase; Weekly before maintenance chemotherapy cycles 1-6 (the worst result within each cycle will be recorded); At the end of treatment or disease progression. whichever came first, assessed up to 36 months.
Brain tumor symptom burden
Assessed using the EORTC QLQ-BN20: Scores are converted to 0-100 scale. Higher symptom domain scores indicate more severe disease-related symptoms.
Measured: Before the concurrent chemoradiotherapy phase; Weekly before maintenance chemotherapy cycles 1-6 (the worst result within each cycle will be recorded); At the end of treatment or disease progression. whichever came first, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- 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
- Model description
- (1) RT: 60 Gy/30 fractions over 6-7 weeks. (2) Chemo: TMZ group gets 75 mg/m² QD during RT, then 6 cycles of maintenance (150-200 mg/m² D1-D5, Q4W). Lenvatinib-TMZ group adds Lenvatinib (20 mg po QD) from Day 1 of RT through maintenance until progression or intolerable toxicity.
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongguan People's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754734
- Sponsor's protocol ID
- IIT-2026-006
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No