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NCT Number: NCT07754734

STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation

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.

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Key information

Conditions

Glioma Astrocytoma Glioblastoma Glioblastoma (GBM) MGMT-Methylated Glioblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):
  • ANC ≥ 1.5 × 10⁹/L; PLT ≥ 100 × 10⁹/L; Hb ≥ 90 g/L.
  • 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.

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:
  • Grade 4 non-hematological toxicity (except hair loss, nausea, vomiting).
  • 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).

Treatment and study plan

Lenvatinib

Drug

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

Radiotherapy

Radiation

Starts 2-6 weeks post-op; total dose 60 Gy (2.0 Gy/fraction, 30 fractions) over 6-7 weeks.

Primary outcomes

  1. Progression-Free Survival（PFS）

    Time frame: 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

    defined as the time from enrollment to the first documented local-regional recurrence, distant metastasis, or death from any cause

Secondary outcomes

  1. Overall survival (OS)

    Time frame: From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 36 months

    defined as the time from enrollment to death from any cause.

  2. Best Overall Response (BOR)

    Time frame: 36 months

    determined by modified RANO criteria for patients with incomplete tumor resection and documented postoperative residual tumor.

  3. Safety evaluation

    Time frame: 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.

    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).

  4. Function quality of Life

    Time frame: 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.

    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.

  5. Brain tumor symptom burden

    Time frame: 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.

    Assessed using the EORTC QLQ-BN20: Scores are converted to 0-100 scale. Higher symptom domain scores indicate more severe disease-related symptoms.

Other outcomes

  1. Exploratory Endpoints (optional)

    Time frame: Before the first dose, after the completion of radiotherapy, and at the time of disease progression, whichever came first, assessed up to 36 months.

    Evaluate tumor tissue biomarkers: Using tumor tissue specimens provided during the screening period, explore the correlation between TERT promoter mutation, 1p/19q deletion, BRAF V600E gene status, as well as the expression levels of Lenvatinib-related targets (e.g., VEGFR 1-3, FGFR 1-4, PDGFRα/β) with the PFS and OS of the subjects through next-generation sequencing (NGS) or immunohistochemistry (IHC) techniques.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhigang Liu, PostDoc Fellow

CONTACT

[email protected]

0769-28637916

Sponsors and collaborators

Lead sponsor

Dongguan People's Hospital

Other Gov

Registry information

Official study title

STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation: A Multicenter, Randomized Phase II Clinical Trial

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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