Low-grade GliomaPhase 3NCT07004075
FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration
A Phase 3 study testing Luvometinib and Chemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, Temozolomide in people with Low-grade Glioma and Pediatric Low-grade Gliomas, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
Trial summary
An open-label, randomized, multi-center phase III clinical study: Aim to evaluate the efficacy and safety of FCN-159 monotherapy versus the treatment by investigator's choice in patients with pediatric low-grade glioma harboring KIAA1549-BRAF fusion or BRAF V600E mutation Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Low-grade Glioma, Pediatric Low-grade Gliomas, pLGG With BRAF Alteration
- What is being tested?
- Luvometinib and Chemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, Temozolomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 30 Apr 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients aged between ≥ 2 years and < 18 years; regardless of male or female.
- Histologically and/or cytologically confirmed diagnosis of low-grade glioma (pLGG diagnosis as Grade 1 or 2 according to the 2021 WHO classification of CNS).
- KIAA1549-BRAF fusion or BRAF V600E mutation-positive.
- Patients requiring systemic therapy as determined by the investigator, including patients having disease recurrence or progression, or residual disease of surgery, or unresectable.
- At least one intracranial measurable lesion that can be reproducibly measured in two dimensions on T2-FLAIR, with the minimum size of the bi-perpendicular diameter of ≥ 10 mm, and can be visible on two or more imaging slice.
- 6. Karnofsky performance score or Lansky performance score ≥ 70. 7．Adequate organ function within 14 days before enrollment.
Who cannot join
- Patients who have previously received any of the following treatments:
- Patients who have received chemotherapy drugs or traditional Chinese medicines or herbals with definitive anti-tumor treatment within 4 weeks preceding the first dose of investigational drug;
- Patients who have received growth factors that promote platelet or leukocyte count or function within 14 days preceding the first dose of investigational drug;
- Patients who received radiotherapy, surgery or immunotherapy within 4 weeks preceding the first dose of investigational drug;
- Patients who have participated in other interventional clinical trials within 4 weeks before receiving the first dose of investigational drug;
- Patients who have received live vaccines within 4 weeks preceding the first dose of investigational drug, or patients who have received inactivated vaccines and mRNA vaccines within 14 days preceding the study treatment;
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- Patients who have previously received any other MEK 1/2 inhibitors such as Selumetinib or BRAF inhibitors such as Dabrafenib.
- Patients with high-grade gliomas, as well as schwannoma, subependymal giant cell astrocytoma (tuberous sclerosis), and diffuse intrinsic pontine gliomas (even if the histological diagnosis is WHO Grade 1 or 2).
- Patients who require endotracheal intubation for assisted ventilation or tracheotomy should be excluded.
- Patients who have uncontrollable epilepsy as assessed by the investigator.
- Patients with dysphagia, active GI diseases, malabsorption syndrome, or other conditions that will interfere with the absorption of the investigational drug.
- Patients with clinically significant active bacterial, fungal or viral infections, including hepatitis B virus surface antigen positive and hepatitis B virus DNA exceeding 1000 IU/ml. Hepatitis B carriers are allowed to be enrolled. Patients with positive hepatitis C virus (HCV) antibody test; those who have confirmed human immunodeficiency virus (HIV) infection, and are unwilling to undergo HIV testing.
- Patients with history or current evidence of retinal vein obstruction (RVO), retinal pigment epithelial detachment (RPED), central retinal vein occlusion, glaucoma, and other significant abnormalities in ophthalmological examinations.
- Interstitial pneumonia, including clinically significant radiation pneumonitis.
- Grade 3 creatine phosphokinase increased (>5 × ULN - 10 × ULN).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Zhuang Kang, +86 15011281069, kzhaoren1984@163.com
About this study
Official title: An Open-label, Randomized, Multi-center Phase III Clinical Study: Aim to Evaluate the Efficacy and Safety of FCN-159 Monotherapy Versus the Treatment by Investigator's Choice in Patients With Pediatric Low-grade Glioma Harboring KIAA1549-BRAF Fusion or BRAF V600E Mutation
An open-label, randomized, multi-center phase III clinical study: Aim to evaluate the efficacy and safety of FCN-159 monotherapy versus the treatment by investigator's choice in patients with pediatric low-grade glioma harboring KIAA1549-BRAF fusion or BRAF V600E mutation
- Being tested
- Luvometinib, Chemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, Temozolomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuvometinibDrug
Luvometinib oral tablet
Chemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, TemozolomideBiological
Investigator's choice of chemotherapy administered IV or orally
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm: Luvometinib | Experimental | FCN-159, 5 mg/m^2, once daily, continuous oral administration Receives: Drug: Luvometinib |
| Comparator: investigator's choice of chemotherapy | Active comparator | Chemotherapeutic Agent COG-V/C, intravenous solution for injection Carboplatin + Vindesine, intravenous solution for injection Carboplatin, intravenous solution for injection Temozolomide, orally Day 1 to Day 5 of each 28 days as a cycle Receives: Biological: Chemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the progression free survival (PFS) of FCN-159 versus chemotherapy by IRC
PFS assessed per RANO-LGG criteria by IRC, and defined as the time from randomization to the first recorded progressive disease or death from any cause, whichever is first
Measured: up to 48 months
Secondary outcomes (7)
PFS of FCN-159 versus chemotherapy by INV
PFS assessed per RANO-LGG criteria by inverstigator
Measured: up to 48 months
Objective response rate (ORR) of FCN-159 versus chemotherapy
ORR assessed per RANO-LGG criteria,and defined as the proportion of patients with confirmed complete response (CR), partial response (PR) or minor response (MR)
Measured: up to 48 months
Clinical benefit rate (CBR) of FCN-159 versus chemotherapy
CBR is defined as the proportion of patients with confirmed CR, PR, MR and SD lasting ≥24 weeks as assessed based on the RANO-LGG criteria
Measured: up to 48 months
Duration of overall response (DOR) of FCN-159 versus chemotherapy
DOR is defined as the time from the date of the first CR, PR or MR to the first recorded tumor progression or death (death due to any cause), whichever occurs earlier
Measured: up to 48 months
Time to response (TTR) of FCN-159 versus chemotherapy
TTR is defined as the time from the first dose of the investigational drug to the first confirmed CR, PR or MR based on the RANO-LGG criteria
Measured: up to 48 months
Overall survival (OS) of FCN-159 vesus chemotherapy
OS is defined as the time from the first dose of the investigational drug to death by any cause
Measured: up to 48 months
Safety of FCN-159 versus chemotherapy
Number of Participants With Adverse Events (AEs) of treated participants
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-grade GliomaStudies of the same condition, open and under way.
- More trials run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004075
- Sponsor's protocol ID
- FCN-159-010
- Status last verified
- May 2025
- First submitted
- 3 Jun 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multi-center Phase III Clinical Study: Aim to Evaluate the Efficacy and Safety of FCN-159 Monotherapy Versus the Treatment by Investigator's Choice in Patients With Pediatric Low-grade Glioma Harboring KIAA1549-BRAF Fusion or BRAF V600E Mutation
- ClinicalTrials.gov ID
- NCT07004075
- Acronym / sponsor ID
- FCN-159-010
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, randomized, multi-center phase III clinical study: Aim to evaluate the efficacy and safety of FCN-159 monotherapy versus the treatment by investigator's choice in patients with pediatric low-grade glioma harboring KIAA1549-BRAF fusion or BRAF V600E mutation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm: Luvometinib | Experimental | Drug: LuvometinibFCN-159, 5 mg/m^2, once daily, continuous oral administration |
| Comparator: investigator's choice of chemotherapy | Active comparator | Biological: Chemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, TemozolomideChemotherapeutic Agent COG-V/C, intravenous solution for injection Carboplatin + Vindesine, intravenous solution for injection Carboplatin, intravenous solution for injection Temozolomide, orally Day 1 to Day 5 of each 28 days as a cycle |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Pediatric patients aged between ≥ 2 years and < 18 years; regardless of male or female.
- Histologically and/or cytologically confirmed diagnosis of low-grade glioma (pLGG diagnosis as Grade 1 or 2 according to the 2021 WHO classification of CNS).
- KIAA1549-BRAF fusion or BRAF V600E mutation-positive.
- Patients requiring systemic therapy as determined by the investigator, including patients having disease recurrence or progression, or residual disease of surgery, or unresectable.
- At least one intracranial measurable lesion that can be reproducibly measured in two dimensions on T2-FLAIR, with the minimum size of the bi-perpendicular diameter of ≥ 10 mm, and can be visible on two or more imaging slice.
Key exclusion criteria (15 listed)
- Patients who have previously received any of the following treatments:
- Patients with high-grade gliomas, as well as schwannoma, subependymal giant cell astrocytoma (tuberous sclerosis), and diffuse intrinsic pontine gliomas (even if the histological diagnosis is WHO Grade 1 or 2).
- Patients who require endotracheal intubation for assisted ventilation or tracheotomy should be excluded.
- Patients who have uncontrollable epilepsy as assessed by the investigator.
- Patients with dysphagia, active GI diseases, malabsorption syndrome, or other conditions that will interfere with the absorption of the investigational drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuvometinibLuvometinib oral tablet | Drug | Experimental arm: Luvometinib |
| Chemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, TemozolomideInvestigator's choice of chemotherapy administered IV or orally | Biological | Comparator: investigator's choice of chemotherapy |
Primary outcome
Compare the progression free survival (PFS) of FCN-159 versus chemotherapy by IRC
Time frame: up to 48 months
PFS assessed per RANO-LGG criteria by IRC, and defined as the time from randomization to the first recorded progressive disease or death from any cause, whichever is first
7 secondary outcomes
PFS of FCN-159 versus chemotherapy by INV
Time frame: up to 48 months
Objective response rate (ORR) of FCN-159 versus chemotherapy
Time frame: up to 48 months
Clinical benefit rate (CBR) of FCN-159 versus chemotherapy
Time frame: up to 48 months
Duration of overall response (DOR) of FCN-159 versus chemotherapy
Time frame: up to 48 months
Time to response (TTR) of FCN-159 versus chemotherapy
Time frame: up to 48 months
Overall survival (OS) of FCN-159 vesus chemotherapy
Time frame: up to 48 months
Safety of FCN-159 versus chemotherapy
Time frame: up to 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
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RecruitingPhase 2
Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
BRAF V600 Mutation, Low-grade Glioma
Active, not recruitingPhase 2
Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
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Active, not recruitingPhase 3
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Luvometinib and Chemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, Temozolomide in people with Low-grade Glioma and Pediatric Low-grade Gliomas, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenbin Li (+86 1530137799, neure55@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the progression free survival (PFS) of FCN-159 versus chemotherapy by IRC (time frame: up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.