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

NCT06812871 | Completed Phase 2

• 1 other identifier: GASTO 10120
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer Metastatic

Keywords

EGFR mutated; meningeal metastasis

Outcome Measures

Primary Outcomes (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,

  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)

• systemic progression-free survival

  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.

• intracranial objective response rate

  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.

• overall survival

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

• safety and tolerability

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

Study Arms (1)

Furmonertinib combined with bevacizumab and intrathecal pemetrexed chemotherapy

EXPERIMENTAL

patients 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).

Drug: furmonertinib

Interventions

furmonertinib DRUG

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).

Also known as: bevacizumab, pemetrexed

Furmonertinib combined with bevacizumab and intrathecal pemetrexed chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological localization is NSCLC;
• confirmed EGFR exon 19 deletion mutation(19del) or EGFR exon 21L858R mutation (L858R) or EGFR exon 20 T790M mutation (T790M)）;
• Clinical diagnosis of meningeal aggravation: clinical symptoms of intracranial hypertension (headache, dizziness, vomiting, etc.) + imaging confirmation (cerebral MRI diagnosis of meningeal aggravation) or cerebrospinal fluid cytology confirmation;
• for patients with symptoms who are considered to need temporary brain local. Treatment of cough receiving adrenal corticosteroids must be kept stable or reponse for at least 1 week before the first trial of the drug preparation;
• Newly diagnosed meningeal 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.
• Obtain informed consent signed by the patient's legal representative;
• Aged ≥18 years and ≤75 years;
• Eastern Tourism Cooperation Group (ECOG) Physical condition evaluation 0-1;
• Life expectancy ≥12 week;
• Able to follow the requirements of the study protocol and confirmation procedures, and able to accept cranial wall medications;
• contraception.

You may not qualify if:

• 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;
• 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）:

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Meningeal Carcinomatosis

Interventions

aflutinib; Bevacizumab; Pemetrexed

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: January 1, 2024
• Primary Completion: October 20, 2025
• Study Completion: March 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)