Lung Cancer
Conditions
Interventions
Single Arm group:Ensartinib
Sponsors
the Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed by histology or cytology; 2. Subject to tissue testing, patients with MET exon 14 skipping mutation status (RT PCR, NGS) confirmed in previous written reports; blood samples should be collected before enrolling patients, and patients are encouraged to obtain biopsy specimens before enrolling; 3. The genetic test report confirms that it is EGFR/ALK/ROS1 wild type; 4. Patients who have not received TKI treatment before; 5. Disease progression or intolerance after receiving at least one platinum-containing chemotherapy (according to RECIST 1.1 criteria); 6. Patients who refuse chemotherapy 7. Gender: Both men and women; Age: >=18 years old; 8. The Eastern Cooperative Oncology Group (ECOG) physical status score is 0-2; 9. Expected survival period >= 3 months; 10. Possess certain organ system function (no blood transfusion or use of blood components within 14 days before the test), defined as follows: absolute neutrophil count >=1.5x10^9/L; platelets >=100x10^9/L; Hemoglobin >= 9 g/dL; total bilirubin 1.5 ULN, the creatinine clearance rate calculated by the Cockcroft-Gault formula >=50 mL/min, or the 24-hour urinary creatinine clearance rate >=50 mL/min, the patient can still be enrolled; 11. Asymptomatic CNS metastases that do not require treatment with steroids or anticonvulsants; 12. The patient has at least one RECIST1.1 measurable lesion; 13. Drug-related toxic reactions other than alopecia should be alleviated to grade 1 or below (CTCAE 4.03 standard); 14. Willing and able to comply with trial and follow-up procedures; 15. Be able to understand the nature of the trial and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Currently receiving other anti-tumor systemic therapy; 2. Patients who participated in clinical trials of other investigational drugs within 4 weeks before the first administration of ensatinib; 3. Major surgery or immunotherapy within 4 weeks before the first dose; radiation therapy within 2 weeks before the first dose; 4. Have severe cardiovascular disease, including but not limited to: QTcF interval >= 450 ms or other significant ECG abnormalities. Investigator-determined poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg). The following occurred within 6 months prior to the first dose: Congestive heart failure. cardiac disease. Arrhythmias or conduction problems requiring pharmacological intervention. Severe/unstable angina, coronary/peripheral bypass graft, or myocardial infarction. Cardiovascular accident or transient ischemia; 5. Active hepatitis B (serum HBV DNA >= 104 copies/ml [ie 20000IU/ml]), positive for hepatitis C virus antibody, positive for HIV antibody, and positive for Treponema pallidum antibody; 6. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any clinically active evidence of interstitial lung disease; 7. Females of childbearing age, pregnant or lactating females with positive serum pregnancy test 7 days before starting treatment, or male and female subjects who did not take effective contraceptive measures or plan to give birth during the entire treatment period and 3 months after the end of treatment; 8. Patients with known allergic reactions to ensatinib or any of the excipients of ensatinib capsules (microcrystalline cellulose, stearic acid, hydroxypropyl methylcellulose).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Disease Control Rate;Duration of Response;Overall Survival;Adverse Events; | — |
Countries
China
Contacts
Public ContactLi Wen
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed