PROCEED
Sponsor study identifier
observational
800
1 country
26
Study Start
September 28, 2026
Actual (reported)Primary Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 28, 2026
Actual (reported)October 2, 2026
Actual (reported)October 22, 2026
Actual (reported)December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
ORR of PN by REiNS criteria.
To describe the objective response rate (ORR) of PN as assessed by the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) criteria
96 weeks
QoL change from baseline by INF1-QoL(IMPACT OF NEUROFIBROMATOSIS 1 ON QUALITY-OF-LIFE) questionnaire.
To assess the change from baseline in quality of life (QoL) using the impact of neurofibromatosis 1 on quality-of-life questionnaire (INF1-QoL) questionnaire. The QoL score ranges from 0 to 42. Higher scores indicate worse quality of life. Therefore, a greater decrease from baseline in the QoL score represents an improvement in quality of life and a better outcome.
96 weeks
The median best tumour volume change of PN from baseline
96 weeks
The change of the diameter of cNF from baseline.
96 weeks
AE/ADRs/SAE.
96 weeks
Percentage of patients with prior PN surgeries
96 weeks
Number of prior PN surgeries
96 weeks
The target population of interest in this study is adult patients (≥18 years of age) with NF1 who have symptomatic, inoperable PN and intend to use selumetinib after enrolment. 800 patients with selumetinib treatment will be enrolled in the study.
Research site
Beijing, China
Research site
Changchun, China
Research site
Changsha, China
Research site
Chengdu, China
Zhichao Wang
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Pinan Liu
Beijing Tiantan Hospital
AstraZeneca Clinical Study Information Center
CONTACT
First Submitted
October 2, 2026
First Posted
October 22, 2026
Study Start
September 28, 2026
Actual (reported)Primary Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Precision Medicine for Neurocutaneous Syndromes in Western China
Contact the study team to confirm eligibility.
Research site
Chongqing, China
Research site
Fuzhou, China
Research site
Guangzhou, China
Research site
Guiyang, China
Research site
Hangzhou, China
Research site
Hefei, China
Research site
Jinan, China
Research site
Kunming, China
Research site
Lanzhou, China
Research site
Nanchang, China
Research site
Nanjing, China
Research site
Nanning, China
Research site
Shanghai, China
Research site
Shenyang, China
Research site
Shenzhen, China
Research site
Shijiazhuang, China
Research site
Suzhou, China
Research site
Ürümqi, China
Research site
Wuhan, China
Research site
Wuhan, China
Research site
Xi'an, China
Research site
Zhengzhou, China
Study Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-10
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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