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Non-small Cell Lung Cancer MetastaticPhase 2NCT06812871

High-dose Furmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Meningeal Metastasis

A Phase 2 study testing furmonertinib in people with Non-small Cell Lung Cancer Metastatic, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

the study conducted to evaluate the efficacy and safety of high-dose furmonertinib (160 mg qd) combined with bevacizumab and pemetrexed intrathecal chemotherapy in NSCLC patients with EGFR mutations and meningeal metastases. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer Metastatic
What is being tested?
furmonertinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
1 Jan 2024to 30 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological confirmed NSCLC;
  • confirmed EGFR sensitive mutations;
  • Diagnosis of leptomeningeal metastases according to the European Association of Neuro-Oncology European Society for Medical Oncology (EANO-ESMO) guidelines: clinical symptoms of intracranial hypertension (headache, dizziness, vomiting, etc.) ; imaging confirmation (cerebral MRI diagnosis of meningeal aggravation) or cerebrospinal fluid cytology confirmation (meets two or more criteria);
  • Patients with mild to minimal CNS symptoms who are tolerable for the treatment were allowed, and given the unique clinical nature of leptomeningeal metastasis, the use of corticosteroid is allowed;
  • Newly diagnosed leptomeningeal metastasis, including meningeal metastasis after previous brain surgery and/or local radiotherapy for solid metastatic disease;
  • Patients did not received systemic treatment after diagnosed meningeal metastases.
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  • Obtain informed consent signed by the patient's legal representative;
  • Aged ≥18 years and ≤75 years;
  • Eastern Tourism Cooperation Group (ECOG) Physical condition evaluation 0-2;
  • Life expectancy ≥12 week;
  • Able to follow the requirements of the study protocol and confirmation procedures, and able to accept cranial wall medications;
  • contraception.

Who cannot join

  • Mixed non-small cell and small cell carcinoma, or squamous cell carcinoma as the main pathological type;
  • history of hypersensitivity reaction to active or inactive excipients of furmonertinib, bevacizumab or pemetrexed or to drugs of similar structure or class to the investigational drug;
  • Currently participating in an interventional clinical trial, or having received other study drugs or study devices within 4 weeks before the first study drug;
  • Patients who have received solid organ or blood system transplantation;
  • Patients with severe intracranial hypertension symptoms that cannot be relieved by discontinuation of dexamethasone and/or glycol treatment, or patients in intensive care;
  • Ensure control of the patient's symptomatic pericardial, peritoneal, and pleural effusions;
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  • History of cancer in the last five years Other malignancies or a history of other malignancies;
  • Recent active digestive events, such as duodenitis, ileitis, intestinal perforation, intestinal catheters, or other conditions that may cause gastrointestinal tract or perforation; or refractory vomiting, chronic gastrointestinal disease, inability to swallow study drugs, or previous colorectal cancer resection that prevents adequate drug absorption;
  • The patient has a physique that is prone to Japanese language learning or has active Japanese language learning; Central squamous cell carcinoma or Patients at greater risk for hemoptysis; Any diamond event ≥ CTCAE grade 3, presence of open wounds, injuries or fractures in the 28th century before the first creation; if in the first Asthma was accepted 28 days before the organization meeting, the wound treatment should be evaluated by the interval period;
  • History of arterial thromboembolism within the last 6 months, including vascular cerebral accident, myocardial infarction, transient cerebral contemplation;
  • History of grade 4 venous thrombosis within the last 6 months, including fire embolism;
  • The presence of any severe or uncontrolled systemic evidence, including difficult-to-control hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), uncontrolled diabetes, etc.;
  • Active infections include, for example, hepatitis B, hepatitis C, and human immunodeficiency virus (HIV) infections (including those requiring intravenous therapy, active hepatitis B infection includes patients with positive hepatitis B surface test based on serological assessment and hepatitis B virus DNA >1000 copies/ml);
  • previous history of interstitial lung disease, drug-induced interstitial lung disease, pneumonitis requiring steroid therapy, or any evidence of active interstitial lung disease;
  • The first 28-day inspection of the drug preparation showed Lack of adequate bone marrow reserve or organ function （Within 2 weeks before blood test, No blood transfusion or blood products, granulocyte colony-stimulating factor or other hematopoietic stimulating factors were used for repair）:
  • Absolute neutrophil count <1.5 × 109/L; continuous count <100×109/L; hemoglobin <90 g/L;
  • Alanine aminotransferase > 2.5 times Upper limit of normal value (Upper limit of normal）; Aspartate aminotransferase>2.5 times ULN; Total bilirubin>1.5 times ULN; or liver transplant patients with AST and/or ALT > 5× ULN;
  • Albumin <30 g/L;
  • Serum creatinine >1.5 times ULN, and Creatinine clearance <50 mL/min （Measured or calculated by Cockcroft and Gault formula);
  • International normalized ratio (INR) > 1.5,Partially activated zymogen time （APTT>1.5 times Upper limit of normal;
  • Urine protein ≥++, and 24-hour protein >2.0g;
  • Any of the following Bishop criteria:
  • Clinically significant resting electrocardiogram rhythm, respiratory, or morphological abnormalities, such as left bundle branch block, third-degree myocardial insufficiency, and second-degree myocardial insufficiency, within 28 days before the first study drug perfume;
  • Possibility Interphase Factors that increase the risk of prolonged or arrhythmic events, such as heart failure, congenital long Quantum Dots Syndrome, long Quantum Dots Family history or first-degree relatives 40 Sudden death due to coma or known prolonged Quantum Dots Any sudden or difficult to fully compensate low potassium tariffs, low tariff tariffs, and low tariff-to-tariff tariffs during the period;
  • Left ventricular ejection fraction (LVEF)Left ventricular ejection fraction）<50%, recent History of myocardial infarction, severe or unstable angina, or coronary artery bypass grafting within the past month or heart failure≥ New York Heart Association (New York Heart Association (NYHA) 2 class;
  • Pregnancy or breastfeeding.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: A Single-arm, Multicenter, Phase 2 Study of High-dose Furmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Meningeal Metastasis

the study conducted to evaluate the efficacy and safety of high-dose furmonertinib (160 mg qd) combined with bevacizumab and pemetrexed intrathecal chemotherapy in NSCLC patients with EGFR mutations and meningeal metastases.

Being tested
furmonertinib
Keywords
EGFR mutated, meningeal metastasis
Medical subject headings
Meningeal Carcinomatosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • furmonertinibDrug

    Also called bevacizumab, pemetrexed

    furmonertinib (160mg, once a day, continuous administration); bevacizumab (7.5 mg/kg body weight, once every 3 weeks); Pemetrexed (50 mg intrathecal injection chemotherapy, once every 3 weeks).

Study groups in NCT06812871
Study groupRoleWhat they receive
Furmonertinib combined with bevacizumab and intrathecal pemetrexed chemotherapyExperimentalpatients receive furmonertinib (160mg, once a day) combined with bevacizumab (7.5 mg/kg, once every 3 weeks) and pemetrexed (50 mg intrathecal injection chemotherapy, once every 3 weeks).
Receives: Drug: furmonertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intracranial progression-free survival

    The time from receipt of study treatment to intracranial tumor PD or to death due to any cause,whichever came first,

    Measured: The time from receipt of study treatment to intracranial tumor PD or to death due to any cause,whichever came first, assessed up to 24 months

Secondary outcomes (4)

  1. systemic progression-free survival

    The time from receipt of study treatment to systemic PD or to death due to any cause,whichever came first,

    Measured: The time from receipt of study treatment to systemic PD or to death due to any cause,whichever came first, assessed up to 24 months.

  2. intracranial objective response rate

    The number and percentage of objective response (PR+CR) of intracranial tumor at each time point after treatment

    Measured: The number and percentage of objective response (PR+CR) of intracranial tumor at each time point after treatment, through study completion, an average of 12 months.

  3. overall survival

    The time interval between enrollment and death from any cause

    Measured: The time interval between enrollment and death from any cause,,whichever came first, assessed up to 24 months.

  4. safety and tolerability

    adverse events will be reported and graded according to the National Cancer Institute (NCI) CTCAE version 5.0.

    Measured: adverse events will be reported and graded according to the National Cancer Institute (NCI) CTCAE version 5.0.,assessed up to 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start1 Jan 2024
  3. Primary completion30 Mar 2026
  4. Study completion30 Jun 2026

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06812871
Sponsor's protocol ID
GASTO 10120
Status last verified
Aug 2026
First submitted
2 Feb 2025
Last updated
14 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing furmonertinib in people with Non-small Cell Lung Cancer Metastatic, run by Sun Yat-sen University 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 12 inclusion and 26 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: finished, as of the sponsor's last update on 14 Aug 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial progression-free survival (time frame: The time from receipt of study treatment to intracranial tumor PD or to death due to any cause,whichever came first, assessed up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06812871.

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 14 Aug 2026.

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