Lung cancer
Conditions
Interventions
Furmonertinib Plus Anlotinib:Furmonertinib 80mg/day orally on a continuous dosing schedule
Anlotinib 12mg/day orally from day 1 to 14 of a 21-day cycle
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects have voluntarily participated, signed and dated informed consent; 2. Male or female subjects aged =18 and =75 years old; 3. The tumor harbors EGFR exon 21 L858R mutation diagnosed histologically or cytologically, the reports must be issued or recognized by Tier 3A hospitals. 4. Locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy (stage IIIB-IV, according to the 8th edition of the AJCC staging system); 5. No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC. For recurrent disease, adjuvant therapy or neoadjuvant therapy may be accepted, but recurrence occurs =6 months from stopping treatment; 6. life expectancy no less than 3 months according to the investigator's assessment; 7. ECOG score 0-1; 8. For patients who have previously received radiation therapy, radiotherapy area must be?25% of bone marrow region, while Whole Pelvic Radiotherapy and Thoracic Radiotherapy are not allowed. 9. Major organs are functioning normally, the following criteria are met: no blood or blood product transfusions, no hematopoietic stimulating factors(G-CSF or others)within 14 days.(HB=90 g/L,ANC=1.5×109/L,PLT=80×109/L);TBIL 45 ml/min(Cockcroft-Gault); 10. Patients with asymptomatic CNS metastases are eligible 11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the first dose, and the pregnancy test (blood or urine test) must be negative; The patient was willing to use the appropriate method of contraception during the trial and 8 weeks after the last administration of the trial drug
Exclusion criteria
Exclusion criteria: 1. Squamous carcinoma (adenosquamous carcinoma), small cell lung cancer (including mixed histology, etc); 2. Patient who receive prior treatment including: any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI); Small molecular TKI of anti-angiogenic; 3. Imaging evidence (CT or MRI) show that the tumor lesions had invaded critical large vessels. Or there is obvious pulmonary cavity or necrotizing tumor; 4. History and complications: Leptomeningeal metastases or central nervous system metastasis requiring emergency treatment;The patient was enrolled in another clinical study or less than 4 weeks after the end of treatment in the previous clinical study;With other malignant tumors at present or history of other malignant tumors within 5 years;;QT prolongation or any clinically important abnormalities in rhythm and heart function; Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, and active infection, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial; 5. Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease; 6. History of hypersensitivity to active or inactive excipients of investigational product (IP) or drugs with a similar chemical structure or class to investigational product (IP); 7. With active infection diseases, such as HBV, HCV and HIV; 8. Patients who may have poor compliance with the research procedures and requirements, etc., as judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Disease progression free survival;Overall Survival;Patient report outcome; | — |
Countries
China
Contacts
Public ContactZhou Jin
Sichuan Cancer Hospital
Outcome results
None listed