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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| systemic progression-free survival | The time from receipt of study treatment to systemic PD or to death due to any cause,whichever came first, | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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):
Any of the following Bishop criteria:
Pregnancy or breastfeeding.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
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|
The number and percentage of objective response (PR+CR) of intracranial tumor at each time point after treatment |
| 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 | 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. | adverse events will be reported and graded according to the National Cancer Institute (NCI) CTCAE version 5.0.,assessed up to 24 months. |
| ID | Term |
|---|---|
| D055756 | Meningeal Carcinomatosis |
| ID | Term |
|---|---|
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000705711 | aflutinib |
| D000068258 | Bevacizumab |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
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