OncoMatch/Clinical Trials/NCT07100730
Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma
Is NCT07100730 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies TLX-101-Tx + Lomustine for neoplastic disease.
Treatment: TLX-101-Tx + Lomustine — This global clinical trial which evaluates the efficacy and safety of TLX101-Tx, an investigational radiopharmaceutical therapy, in combination with lomustine versus lomustine alone in adult patients with first recurrence of glioblastoma. TLX101-Tx delivers targeted radiation to glioblastoma cells. The trial is conducted in two parts: Part 1 assesses safety and radiation dosing; Part 2 is a randomized comparison of the combination therapy against standard care.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Disease stage
Required: Stage PROGRESSIVE (WHO 2021, RANO 2.0)
Grade: IV (WHO)
Radiographic evidence of first recurrence or progressive glioblastoma according to RANO 2.0 criteria after first-line treatment...measurable per PET RANO 1.0 criteria
Performance status
ECOG OR KPS 0–2
Prior therapy
Must have received: standard radiotherapy or chemoradiotherapy — first-line
first-line treatment with biopsy or maximal safe resection and standard radiotherapy or chemoradiotherapy
Cannot have received: nitrosoureas
Any systemic antineoplastic treatment other than nitroureas
Cannot have received: external beam radiation
Exception: allowed if >3 months prior
Prior course with external beam radiation to the brain in the past 3 months
Cannot have received: brachytherapy
Prior treatment with brachytherapy in the brain
Cannot have received: bevacizumab (bevacizumab)
Treatment with bevacizumab within the prior 6 weeks
Cannot have received: investigational product
Administration of another investigational product within 90 days prior to screening
Lab requirements
Blood counts
Adequate hematological function at the time of screening
Kidney function
Adequate renal function at the time of screening
Liver function
Adequate liver function at the time of screening
Adequate hematological, liver and renal function at the time of screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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