Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) with Brain Metastases
Conditions
Interventions
Furmonertinib Standard Dose Group (80mg):NA
Furmonertinib High Dose Group (160mg):NA
Furmonertinib in combination with chemotherapy:NA
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Provide informed consent before any study-specific procedures; 2. Be aged 18 years and older, and no older than 75 years (inclusive of 18 and 75 years); 3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and no deterioration in the 2 weeks prior to enrollment, with an expected life expectancy of =12 weeks; 4. Be histologically or cytologically confirmed with advanced non-small cell lung cancer (NSCLC) [American Joint Committee on Cancer (AJCC) 8th edition TNM staging IV]; 5. Have a histological or cytological report from a third-grade A-level hospital confirming the presence of EGFR 19DEL or L858R mutations, which can exist alone or together; 6. Not have received systemic anti-tumor treatment for advanced/metastatic NSCLC before the start of study drug treatment, including standard chemotherapy, biological therapy, targeted therapy, immunotherapy, or experimental drug treatment; patients who have received adjuvant or neoadjuvant treatment (chemotherapy and/or radiotherapy) may be enrolled if there is no progression within 6 months after treatment; patients who have received local treatment (radiotherapy or pleural cavity perfusion) may be enrolled if the lesion within the treated area is a non-target lesion; 7. Have at least one measurable CNS metastatic lesion that has not been irradiated and has not undergone tissue biopsy during the screening period, as confirmed by the investigator, according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1); 8. Have adequate organ and bone marrow function (without blood transfusion or use of hematopoietic stimulating agents within 14 days): Absolute neutrophil count >=1.5×10^9/L; Platelet count >=100×10^9/L; Hemoglobin >=90 g/L; Liver function: Total bilirubin =60 mL/min (calculated using the Cockcroft Gault formula); Coagulation function: International Normalized Ratio (INR) 50% as determined by echocardiogram; 9.Female participants must use highly effective contraception (see restriction provisions) at least 2 weeks before starting the study drug, have a negative pregnancy test, and not be breastfeeding at the time of starting the medication. Male participants should be willing to use barrier contraception, i.e., condoms (see restriction provisions).
Exclusion criteria
Exclusion criteria: 1. Presence of small cell lung cancer components; 2. Known hypersensitivity history to active or inactive excipients of Furmonertinib or drugs with similar structures or categories to the test drug; 3. Confirmed EGFR exon 20 insertion mutation; 4. Patients who have received any of the following treatments before the start of study drug treatment: • Any EGFR-TKI treatment; • Patients who have received pleural cavity perfusion treatment must have stable pleural effusion for 28 days or more before enrollment; • Major surgery within 28 days before the first dose of study drug; • Radiotherapy to an area >=30% of the bone marrow or extensive radiotherapy within 28 days before the first dose of study drug; local radiotherapy or palliative radiotherapy for bone metastases within 14 days before the first dose of study drug; • Use of strong inhibitors or inducers of CYP3A4 within 7 days before the first dose, or patients who need to continue receiving these medications during the study; • Use of traditional Chinese medicine and proprietary Chinese medicine preparations indicated for anti-tumor within 7 days before the first dose, or patients who need to continue receiving these medications during the study; • Patients currently receiving medications known to prolong QTc interval or cause torsades de pointes ventricular tachycardia, and who need to continue receiving these medications during the study; • The time since discontinuation of other experimental drugs has not been at least 5 half-lives or 2 months (whichever is longer) before the first dose; 5. Patients who have previously received systemic anti-tumor treatment for advanced/metastatic non-small cell lung cancer (such as standard chemotherapy, biological therapy, targeted therapy, immunotherapy, or experimental drug treatment, etc.), with neoadjuvant and adjuvant treatments referred to enrollment criterion 6; 6. At the start of study drug treatment, previous anti-tumor treatment-related toxicities have not recovered to <= CTCAE grade 1, except for hair loss or chemotherapy-induced <= CTCAE grade 2 peripheral neuropathy; 7. Patients who have received local radiotherapy for brain metastases must have stable symptoms for 14 days or more after radiotherapy before enrollment; 8. History of other malignancies within the last 5 years or other malignant tumor history, except for effectively controlled skin basal cell carcinoma, cervical carcinoma in situ, and breast ductal carcinoma in situ; 9. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the study drug, or conditions that interfere with the adequate absorption of Furmonertinib, such as prior colectomy; 10. Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes, and active bleeding, etc., that the investigator believes may interfere with the patient’s participation in the study or compromise compliance with the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV) (including any patient receiving intravenous treatment for infection; active hepatitis B infection at least includes all patients positive for hepatitis B surface antigen based on serological assessment); 11. History of interstitial lung disease, drug-induced interstitial lung disease, past history of radiation pneumonia requiring steroid treatment, or any evidence of active interstitial lung disease; 12. Any evidence of corneal injury di
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Objective central nervous system response rate, CNS ORR ;Disease control rate, DCR;Central nervous system disease control rate, CNS DCR;Central nervous system progression-free survival, CNS PFS ;1-year central nervous system progression-free survival;2-years central nervous system progression-free survival;Objective Response Rate, ORR ; | — |
Countries
China
Contacts
Public ContactGuanming Jiang
Dongguan People's Hospital
Outcome results
None listed