NSCLC
Conditions
Interventions
single arm:Amitini
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 or over, regardless of gender; 2. Patients with squamous or non squamous NSCLC confirmed by histology or cytology (according to the eighth edition of IASLC); 3. Patients with EGFR mutations (including g719x, exon 19 deletion, L858R, l861q) that have been confirmed to be related to EGFR TKI sensitivity; 4. Patients with clinical stage III (according to the eighth AJCC stage); 5. At least one tumor focus of the patient has not been irradiated before, and has not received tissue biopsy in the screening period, and can be accurately measured at the baseline. The longest diameter at the baseline period is >= 10 mm (in case of lymph nodes, the short axis is required to be >= 15 mm). The selected measurement method is suitable for accurate repeated measurement, which can be computed tomography (CT) or magnetic resonance imaging (MRI); 6. Who patients with a functional state score of 0-1 and no deterioration in the previous 2 weeks; 7. Patients with expected minimum life expectancy of 12 weeks; 8. Patients who have not received systematic anti-tumor treatment before (including EGFR or ALK inhibitors or ros1 inhibitors); 9. Women of childbearing age need to take appropriate contraceptive measures in the research process. Lactation should not be carried out during the screening phase, the study phase and within 3 months after the end of the study. Prior to the start of administration, the pregnancy test was negative, or one of the following criteria was met to demonstrate that there was no risk of pregnancy: (1) Postmenopause is defined as amenorrhea for at least 12 months after the age of 50 years or the cessation of all hormone replacement therapy; (2) Women younger than 50 years of age can also be considered postmenopausal if they have been amenorrhoea for 12 months or more after stopping all exogenous hormone therapy. In addition, the levels of LH and FSH were within the reference values of postmenopausal women; (3) She has undergone irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral salpingectomy, except for bilateral tubal ligation; 10. Male patients should be willing to use barrier contraception (i.e. condom); 11. At least one non target lesion suitable for multiple biopsies was found in the patients of matched biopsies in dose expansion period; 12. The function of liver and kidney should conform to: (1) TBIL = 40 ml / min / 1.73 m2); 13. Good bone marrow function: (1) Hemoglobin (HB) >= 9.0 g / dl; (2) Neutrophil absolute value (ANC) >= 1.5 * 10^9 / L; (3) Platelet count (PLT) >= 100 * 10^9 / L; 14. Patients who voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have received EGFR or ALK inhibitors or systemic therapy or PD-1 or PD-L1 as the target; 2. Spinal cord compression or brain metastasis, except for asymptomatic, stable patients, who do not need steroids at least 4 weeks before the start of study treatment; 3. For patients with evidence of any serious or uncontrolled systemic disease, including uncontrolled hypertension or active bleeding prone constitution, in the opinion of researchers, patients are not suitable to participate in the trial or will affect patients' compliance with the program, such as active infection (such as hepatitis B, hepatitis C or human immunodeficiency virus [HIV]). No need to check chronic diseases; 4. Meet any of the following cardiac standards: (1) The mean corrected QT interval (QTC) > 470 msec was obtained from 3 ECG examinations in resting state, and QTCF was corrected by friderica formula. (2) Resting ECG indicated various clinically significant rhythm, conduction or EKG morphological abnormalities (e.g., complete left bundle branch block, 3-degree AV block, 2-degree AV block, PR interval > 250 msec). (3) There are any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, long QT syndrome family history or unexplained sudden death of immediate family members under 40 years old or any combination drugs that extend QT interval. (4) LVEF 2.5 times the upper limit of normal (ULN); if there is liver metastasis, > 5 * ULN. (5) If there is no definite liver metastasis, aspartate transaminase is more than 2.5 * ULN; if there is liver metastasis, it is more than 5 * ULN. (6) If there is no definite liver metastasis, total bilirubin > 1.5 * ULN; or Gilbert syndrome (unconjugated hyperbilirubinemia) or liver metastasis, > 3 * ULN. (7) Creatinine > 1.5 * ULN and creatinine clearance 1.5 * ULN. 7. Patients with intractable nausea, vomiting or chronic gastrointestinal diseases who cannot swallow the study drug or have undergone a large-scale enterotomy may affect the full absorption of amitinib. 8. Patients who have a history of hypersensitivity to any active or non active component of amitinib or to drugs with similar chemical structure or the same class of amitinib; 9. Women with positive pregnancy test results in blood or urine during lactation or screening follow-up; 10. Personnel involved in the research plan and Implementation (i.e. research center staff); 11. According to the judgment of the researcher, the compliance of the procedure, restriction and requirement of the study may not be good, and it is not suitable for the patients in the group; 12. Any disease or condition that, in the opinion of the investigator, endangers the safety of the patient or interferes with the evaluation of the study; 13. Patients wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;MPR; | — |
Countries
China
Contacts
Public ContactWang Xiaohua
Jiangsu Cancer Hospital
Outcome results
None listed