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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.

Phase 3RecruitingTelix Pharmaceuticals (Innovations) Pty LimitedNCT07100730Data as of May 2026

Treatment: TLX-101-Tx + LomustineThis 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.

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Extracted 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

Min 1 prior line

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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