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Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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 had not received previous systemic treatment for advanced NSCLC or had meningeal metastases after treatment with one third-generation EGFR-TKI.
  • - 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.

Exclusion Criteria:

  • - Mixed non-small cell and small cell carcinoma, or squamous cell carcinoma as the main pathological type; - Known EGFR exon 20 C797X mutation (C797X); - 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; - Brain metastases have previously received whole-brain radiotherapy; - 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 orPatients 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06812871
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sun Yat-sen University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Non-small Cell Lung Cancer Metastatic
Arms & Interventions

Arms

Experimental: Furmonertinib combined with bevacizumab and intrathecal pemetrexed chemotherapy

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, up to 9 cycles).

Interventions

Drug: - furmonertinib

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, up to 9 cycles).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sun Yat-Sen University Cancer Center, Guangzhou 1809858, Guangdong 1809935, China

Status

Recruiting

Address

Sun Yat-Sen University Cancer Center

Guangzhou 1809858, Guangdong 1809935, 510000

Site Contact

Likun Chen

[email protected]

+8613798019964

Nearest Location

Site Contact

Likun Chen

[email protected]

+8613798019964


Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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