OncoMatch/Clinical Trials/NCT07888517
Observational Study of the Real-world Effectiveness and Safety of Selumetinib Treating Adult Patients With Neurofibromatosis Type 1 (NF1) Who Have Symptomatic, Inoperable Plexiform Neurofibroma (PN)
Is NCT07888517 recruiting? Yes, currently enrolling (Oct 2026).
This is a prospective, multicentre, observational registry study with primary data collection designed to evaluate the real-world effectiveness and safety of selumetinib in adult patients with NF1 who have symptomatic, inoperable PN. A total of approximately 800 participants who initiate selumetinib treatment will be enrolled across about 45 investigational sites in China. Sites will be selected based on their diagnostic and treatment expertise in NF1-PN, research capability and sufficient patient pool. Patients who are eligible and willing to participate will be enrolled into the study. The study includes an approximately 25-month enrolment period and a 96-week observation period. Patients will be followed up until the end of the 96-weeks observation period after first dose of selumetinib, or patient death, lost to follow-up, withdrawal of consent, whichever occurs first. Patients will be followed within 96 weeks period (starting after first dose received) in the study even if selumetinib is discontinued. The study will end until the last participant has the opportunity to complete 96 weeks' assessment.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: NF1 heterozygous pathogenic variant
Prior therapy
Must have received: selumetinib (selumetinib)
Have a documented treatment plan or prescription for selumetinib in the medical records as assessed by the investigator, indicating the decision to initiate selumetinib treatment
Cannot have received: MEK inhibitor
Have had prior treatment with a MEKi
Cannot have received: Ras inhibitor
Have had prior treatment with a Ras inhibitor
Cannot have received: Raf inhibitor
Have had prior treatment with a Raf inhibitor
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07888517 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior MEK inhibitor, Ras inhibitor, Raf inhibitor disqualifies patients from enrollment.
Does this trial require NF1?
Yes, NF1 heterozygous pathogenic variant is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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