Phase 3 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have signed a written consent form before joining the trial, as required by international research guidelines.
• People whose glioblastoma has come back or progressed for the first time after standard chemotherapy and radiation treatment, with that progression happening at least 6 months after radiation ended.
• People whose tumour can be measured on imaging scans and is no larger than 5 cm across.
• People who had surgery for their returning tumour must have fully recovered, have the recurrence confirmed by tissue testing, and be considered well enough to take part by their doctor.
• People who have a confirmed laboratory diagnosis of glioblastoma, IDH wildtype, based on WHO 2021 classification, from either their original diagnosis or from recurrence.
• People whose original glioblastoma was treated with surgery to remove as much of the tumour as safely possible, followed by combined chemotherapy and radiation (at least 15 radiation sessions), with or without further temozolomide chemotherapy — and who received at least one dose of that chemotherapy.
• People whose steroid dose has been stable or decreasing for at least 7 days before joining the trial.
• People aged 18 or older.
• People with a WHO performance status of 0–2, meaning they are able to carry out daily activities independently or with only mild limitations.
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting the study treatment.
• People who are able to become pregnant or father a child must agree to use highly effective contraception during treatment and for at least 6 months after the last dose.
• Women who are breastfeeding must stop breastfeeding before the first dose and for 6 months after the last dose.
• Men who have not had a vasectomy must use contraception during treatment and for 6 months after the last dose.
• Men who have not had a vasectomy must avoid donating sperm for the duration of the study and for at least 6 months after the last dose.

Who may not be able to join:

• People who have already received any cancer treatment (other than surgery) for their recurrent glioblastoma.
• People with significantly low platelet or white blood cell counts, or with serious kidney problems, as assessed by the investigating doctor.
• People with a history of, or current, acute leukaemia or any other myeloid blood disease.
• People with a known allergy or sensitivity to lomustine (the study drug) or any of its ingredients.
• People with known coeliac disease or a wheat allergy.
• People who have received a live vaccine within the 3 months before starting lomustine.
• People with a serious or uncontrolled medical condition — such as active infection, chronic alcohol dependence, or drug addiction — that in the doctor's judgement would prevent safe participation or completing the study.
• People with a known reason they cannot receive the imaging contrast agents or tracers used in this trial, or who cannot have an MRI scan.
• People with psychological, family, social, or geographical circumstances that could make it difficult to follow the study plan and attend follow-up appointments (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.