non-small cell lung cancer
Conditions
Interventions
Experimental group:Fumetinib mesylate qd+ anlotinib hydrochloride qd
Sponsors
The General Hospital of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. No gender limit, aged >=18 years (including the cut-off value). 2. ECOG score 0-2, life expectancy is not less than 12 weeks. 3. Patients with histologically or cytologically proven locally advanced or metastatic NSCLC who are not candidates for surgery or radiotherapy. 4. Patients with EGFR or T790M mutation were confirmed by different detection methods. 5. Patients who have received osimertinib mesylate in the past (last treatment with osimertinib mesylate) after progression. Patients received osimertinib mesylate for at least 4 weeks before progression. 6. According to RECIST1.1, at least one lesion (computed tomography [CT], positron emission computed tomography [PET-CT], magnetic resonance imaging [MRI]) could be measured. 7. The organ function level must meet the following requirements: (1) Neutrophil absolute value >=1.5x10^9/L, platelet count >=75x10^9/L, hemoglobin >=90g/L; (2) Serum total bilirubin =50ml/min. CockcroftandGault formula. 8. Have recovered to grade 1 or less from toxicities associated with previous anticancer therapy. 9. For premenopausal women who may have children, a pregnancy test must be done within 7 days before the first medication, and the pregnancy test must be negative and must be non-lactation; All enrolled patients (male or female) should use adequate barrier contraception throughout the treatment period and for 3 months after the end of treatment. 10. Enrolled voluntarily and signed the informed consent, followed the trial treatment plan and visit plan.
Exclusion criteria
Exclusion criteria: 1. Patients who had previously been treated with targeted agents combined with antiangiogenic regimens. 2. The patient was using and could not discontinue the following drugs within 1 week before the first administration of the study therapy: CYP3A4 strong suppressor or inducer; Traditional Chinese medicine and its preparations with anti-tumor indications; Traditional Chinese medicine and traditional Chinese medicine preparations with adjuvant tumor therapy; The investigators determined that the treatment of the subjects was not necessary and had antitumor activity. 3. Prior platinum-based treaty-related neuropathy could be extended to grade 2 at the time of study treatment initiation if there was still unhealed toxicity from previous treatment and the CTCAE grade for adverse events exceeded grade 1 (except hair loss). 4. Spinal cord compression or symptomatic and untreated brain metastases (except those who are asymptomatic, stable, and do not require steroid therapy for more than 4 weeks prior to study treatment initiation). 5. There is any clinical evidence of severe or uncontrolled systemic disease, such as ineligibility by the investigator, or patients with uncontrolled hypertension, active bleeding predisposition, active infections such as hepatitis B (HBV-DNA>=1000cps/ml), hepatitis C, or human immunodeficiency virus (HIV) infection (except hepatitis B virus carriers deemed eligible for enrollment by the investigator) that would affect adherence to the study protocol. 6. Any condition that affects the patient's ingestion of the drug and significantly affects the absorption of the trial drug, including any kind of uncontrollable nausea and vomiting, chronic gastrointestinal disease, the patient's inability to swallow pharmaceutical preparations, and a history of gastrointestinal resection or surgery. 7. Meet any of the following cardiac criteria: in the resting state, the mean corrected QT interval (QTc) obtained from electrocardiogram (ECG) examination is >470msec (QTcB=QT/RR1/2, the first abnormal, retest within 48 hours, calculated as the average of the two results). Various clinically significant abnormalities in rhythm, conduction, and resting ECG morphology, such as complete left bundle branch block, degree III block, degree II block, PR interval >250msec. Factors that may increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome in a first-degree relative or sudden unexplained death before the age of 40 years, and ongoing use of any medication with known QT prolongation. 8. A past history of interstitial lung disease, drug-induced interstitial lung disease, and radiation pneumonitis requiring steroid treatment. 9. There were acute or progressive pulmonary symptoms that were considered ineligible for enrollment by the investigator or high-risk factors that were considered ineligible for enrollment because of the possibility of interstitial lung disease. 10. Patients who were deemed ineligible for the study by the investigator for other reasons (e.g. not suitable to participate in the study; Those who have undergone allogeneic bone marrow transplantation and are not suitable to participate in this study; Coexisting with other malignant tumors, which is not suitable for participating in this study; The patient has a history of hypersensitivity reaction to active or inactive excipients of the study drug, drugs with che
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;Duration of Overall Response;Disease Control Rate;Clinical Benefit Rate;Safety; | — |
Countries
China
Contacts
Public ContactWang Jinliang
The General Hospital of the People's Liberation
Outcome results
None listed