EGFR-mutated advanced NSCLC patients with brain or leptomeningeal metastases
Conditions
Interventions
Cohort 1: Treatment-naive EGFR-mutated advanced NSCLC with brain metastases:Furmonertinib (160 mg, orally once daily) combined with anlotinib (10 mg, orally once daily on Days 1-14 of a 21-day cycle)
Cohort 2: EGFR-mutated advanced NSCLC with leptomeningeal metastases (diagnosed per EANO-ESMO criteria):Furmonertinib (160 mg, orally once daily) combined with anlotinib (10 mg, orally once daily on D
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 and = 12 weeks as judged by the investigator; 8.Adequate organ function meeting the following criteria: Hematological parameters (no blood transfusion or blood products within 14 days): a. Hemoglobin (Hb) >= 90 g/L b. Absolute neutrophil count (ANC) >= 1.5×10^9/L c. Platelet count (PLT) >= 100×10^9/L; Biochemical parameters: d. Total bilirubin (TBIL) 45 mL/min (calculated by Cockcroft-Gault formula); 9.Premenopausal women of childbearing potential must have negative serum or urine pregnancy test within 7 days prior to first dose; 10.All subjects must voluntarily participate and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Non-lung adenocarcinoma histology, including squamous cell carcinoma or mixed histological types; 2.Expected to receive other anti-tumor therapy other than the investigational product during the study; 3.Having a history of other malignant tumor, or other concurrent malignant tumors in the past two years, except for basal cell carcinoma of the skin, cervical carcinoma in situ and breast ductal carcinoma in situ that have been effectively controlled; 4.Cohort 1: Presence of spinal compression or symptomatic CNS metastasis; except the patients with no symptoms, stable condition or no need to use steroids for 14 days or above prior to the start of study treatment, the patients who have received local radiotherapy for brain metastasis can be enrolled only after the brain metastasis symptoms are stable for 14 days or above, after the end of radiotherapy; 5.The patient has severe digestive tract diseases that affect drug administration and absorption, including but not limited to peptic ulcer, inflammatory bowel disease, etc.; 6.Known or suspected allergy to Furmonertinib, anlotinib, or other components of its preparation; 7.Use of a potent CYP3A4 inhibitor or inducer within 7 days prior to the first dose of investigational product or expected to be required during the study; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study; 8.Known previous history of interstitial lung disease, drug induced interstitial lung disease, radiation pneumonitis requiring steroid treatment; or acute attack of or ongoing pulmonary symptoms that are considered by investigators as unsuitable for enrollment, or high-risk factors that are judged as possible interstitial lung disease and unsuitable for enrollment at baseline; 9.Presence of significant arrhythmias (eg, prolonged QT interval > 470 milliseconds) or heart failure (left ventricular ejection fraction < 50%); 10.Female patients in pregnancy or lactation; 11.Participation in other clinical trials within 4 weeks; 12.Other conditions considered inappropriate for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival in Cohort 1 and Cohort 2; | — |
Secondary
| Measure | Time frame |
|---|---|
| iORR in Cohort 1 and Cohort 2;Safety in Cohort 1 and Cohort 2;iDCR in Cohort 1 and Cohort 2;iPFS in Cohort 1 and Cohort 2;Objective Response Rate in Cohort 1 and Cohort 2;Disease Control Rate in Cohort 1 and Cohort 2; | — |
Countries
China
Contacts
Public ContactWang Haiyong
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed