Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma (IPAX BrIGHT)

• Combination Product: TLX-101-Tx + Lomustine
• Radiation: TLX101-Tx

Inclusion Criteria

1. Previously confirmed neuropathological diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of glioblastoma, IDH-wildtype according to the WHO 2021 classification.
2. Radiographic evidence of first recurrence or progressive glioblastoma according to RANO 2.0 criteria after first-line treatment with biopsyremoval of a section of tissue to analyse for cancer cells or maximal safe resectionsurgical removal of tissue or part/all of an organ and standard radiotherapy or chemoradiotherapy having occurred at least 3 months after the end of prior radiotherapy. Prior first-line therapy may include a combination of:
   1. Any systemic antineoplastic treatment other than nitroureas
   2. Tumor-treating fields
   3. Conventionally fractionated or abbreviated (minimum 15 fractions) radiotherapy
3. Increased [18F]]FET PET tracer uptake inside or in the vicinity of tumor. Specifically, amino acid-based molecular imagingtests that create detailed images of areas inside the body using [18F]FET PET will be evaluated following co-registration with MRI. The allocated physician/reader will assess whether the observed pathologically increased amino acid uptake is located within the tumor or in the vicinity. This determination will serve as a guidance to confirm whether the uptake is tumor-associated. The uptake must be clearly discernible from background activity and measurable per PET RANO 1.0 criteria, as determined by central review.
4. Tumor debulkingremoval of as much of the tumour as possible when complete tumour removal is not possible, also known as cytoreduction for recurrent, progressive disease is allowed. The patient must have post-surgical (4-6 weeks) radiographic evidence for residual tumor according to RANO 2.0 with increased [18F] FET PET uptake and measurable disease according to PET RANO 1.0.
5. 18 years or older
6. Have the capacity to understand the study and be willing to comply with all protocol requirements.
7. Must have an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Status (PS) of 0-2 or KPS≥70
8. Patients on stable, not increasing dosethe amount of medication taken of steroids in the previous 7 days can be included in the study
9. Adequate hematological, liver and renal function at the time of screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.
10. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of investigational drug product; must not be breast-feeding; and must agree to use a highly effective method of contraception during treatment and for 6 months following last dose of investigational product.
11. Male patients must agree to use condoms during sex during the treatment period and for 3 months after the last dose of the investigational drug product and must not make semen donations during treatment and for 6 months following last dose of investigational drug product. For male patients with female partners of childbearing potential, females must agree to use a highly effective method of contraception during the treatment period and for 6 months following last dose of investigational drug product.