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New study tracks Selumetinib's Real-World impact on kids with NF1 tumors

NCT ID NCT06175637

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study follows about 80-100 Chinese children aged 3-16 with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas. All participants take the drug selumetinib (Koselugo) and are monitored for 24 months to see how well it works and what side effects occur in everyday medical practice. The goal is to better understand the disease and treatment patterns in China.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Selumetinib (Koselugo)
What this could lead to
If successful, this study could confirm that selumetinib works well and is safe for Chinese children with NF1-related tumors, potentially leading to broader access and better management of the disease.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It only includes Chinese children, so findings may not apply to other populations. Side effects of selumetinib are possible, and the study does not test a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

409 people

The number who actually took part.

Started

Dec 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The target population of interest in this study is pediatric patients with neurofibromatosis type 1 (NF1) aged 3-16 years (3 and 16 years are inclusive) who have symptomatic, inoperable plexiform neurofibromas (PN) and intend to use selumetinib after enrollment. Each eligible patient should meet all of the inclusion criteria and none of the exclusion criteria. At least 80 and no more than 100 eligible patients will be enrolled in the study.

Ages

3 to 16 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * (1) 3≤ age ≤16 years old at the time of study enrollment; (2) Diagnosed with NF1 as per the revised 2021 Guidelines; (3) Have symptomatic, inoperable PN: (4) Intend to use selumetinib after enrollment; (5) Able to give written informed consent. Data collection must only be done after obtaining written informed consent. Patient or patient's parent/legal guardian must be willing and able to give written informed consent. Parent or legal guardian consent is required in the assent process with appropriate documentation. Mandatory provision of signed and dated parent/legal guardian consent for the study along with the pediatric assent form, when applicable. Exclusion Criteria: * (1) Evidence of MPNST, prior malignancy or other cancer requiring treatment with chemotherapy or radiation therapy; (2) A life-threatening illness, medical condition, or organ system dysfunction; (3) Have had prior treatment with a MEKi, Ras or Raf inhibitor; (4) Patients currently participating in any clinical trials at the time of enrollment or initiation of selumetinib.

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Conditions

The condition(s) this trial relates to.

plexiform neurofibroma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neurofibroma, plexiform

Contacts and locations

Locations

  • Research Site

    Beijing, Beijing Municipality, China

  • Research Site

    Chongqing, Chongqing Municipality, China

  • Research Site

    Lanzhou, Gansu, China

  • Research Site

    Guangzhou, Guangdong, China

  • Research Site

    Shenzhen, Guangdong, China

  • Research Site

    Nanning, Guangxi, China

  • Research Site

    Guiyang, Guizhou, China

  • Research Site

    Shijiazhuang, Hebei, China

  • Research Site

    Zhengzhou, Henan, China

  • Research Site

    Wuhan, Hubei, China

  • Research Site

    Changsha, Hunan, China

  • Research Site

    Nanjing, Jiangsu, China

  • Research Site

    Suzhou, Jiangsu, China

  • Research Site

    Nanchang, Jiangxi, China

  • Research Site

    Shenyang, Liaoning, China

  • Research Site

    Jinan, Shandong, China

  • Research Site

    Shanghai, Shanghai Municipality, China

  • Research Site

    Taiyuan, Shanxi, China

  • Research Site

    Xi’an, Shanxi, China

  • Research Site

    Chengdu, Sichuan, China

  • Research Site

    Tianjin, Tianjin Municipality, China

  • Research Site

    Kunming, Yunnan, China

  • Research Site

    Hangzhou, Zhejiang, China

  • Research Site

    Wenzhou, Zhejiang, China

  • Research Site

    Nanjing, China

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