Non-small-cell lung carcinoma
Conditions
Interventions
Experimental group:received 110 mg of Almonertinib orally once a day
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Histologically or cytologically diagnosed as locally advanced or metastatic NSCLC; 3. The CTCAE >= grade 3 AE related to osimertinib treatment in previous treatment with osimertinib, or platelet count =CTCAE grade 2), white blood cell count = CTCAE grade 2), total bilirubin> 1.5xULN (>=CTCAE grade 2), transaminase (ALT/AST)>3.0xULN (>=CTCAE grade 2), and the toxic reaction has been alleviated or restored to =10 mm (if it is a lymph node, the short diameter is required to be >=15 mm). The selected measurement method is suitable for accurate repeat measurement, which can be computed tomography (CT) or magnetic resonance scan (MRI). If there is only one measurable lesion, it can be accepted as the target lesion, and a baseline assessment of the tumor lesion should be performed at least 14 days after the diagnostic biopsy; 7. Women of childbearing age should take appropriate contraceptive measures from screening to 3 months after stopping the study treatment and should not breastfeed. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy: (1) Postmenopausal is defined as amenorrhea at least 12 months after the age is over 50 years and all exogenous hormone replacement therapy is stopped; (2) For women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels are within the laboratory postmenopausal reference value range, also It can be considered postmenopausal; (3) Have received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral tubal ligation. 8. Male patients should use barrier contraception (i.e. condoms) from screening to 3 months after stopping the study treatment; 9. The subjects themselves participated voluntarily and signed an informed consent form in writing.
Exclusion criteria
Exclusion criteria: 1. Have received any of the following treatments: (1) Have previously received any EGFR tyrosine kinase inhibitor treatment except osimertinib; (2) The patient had undergone major surgery within 4 weeks before the first administration; (3) Accept other test drugs, and within 5 half-lives; (4) Within 7 days before the first administration of the study drug, CYP3A4 strong inhibitors, inducers, or drugs with a narrow therapeutic window that are CYP3A4 sensitive substrates have been used. 2. Patients with other malignant tumors who need standard treatment or major surgery within 2 years after the first administration of the study treatment; 3. As judged by the investigator, there are any serious or poorly controlled systemic diseases, such as poorly controlled hypertension, active bleeding-prone constitution, or active infection. No need to check for chronic diseases; 4. Refractory nausea, vomiting or chronic gastrointestinal disease, inability to swallow study drugs or having undergone extensive bowel resection may affect the full absorption of Ametinib; 5. A history of interstitial lung disease, a history of drug-induced interstitial lung disease, a history of interstitial pneumonia requiring steroid therapy, or any evidence of clinically active interstitial lung disease; 6. Meet any of the following cardiac examination results: (1) The average corrected QT interval (QTc)> 470 msec obtained from 3 ECG examinations in the resting state, the Fridericia formula is used for QT interval correction (QTcF); (2) Resting ECG suggests that there are various clinically significant rhythms, conduction or ECG morphological abnormalities (such as complete left bundle branch block, 3 degree atrioventricular block, 2 degree atrioventricular block, and PR between Period> 250 msec); (3) There are any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death or prolonged QT of immediate family members under the age of 40 Any concomitant drugs in the interval; (4) Left ventricular ejection fraction (LVEF) 2.5 times the upper limit of normal (ULN); (5) Aspartate aminotransferase> 2.5xULN; (6) Total bilirubin> 1.5xULN; or Gilbert syndrome (unconjugated hyperbilirubinemia); (7) Creatinine>1.5xULN and creatinine clearance rate1.5xULN, creatinine clearance rate needs to be confirmed. 8. Women who are breastfeeding or whose blood or urine pregnancy test results are positive within 3 days before the first dose of study treatment; 9. Active fungal, bacterial and/or viral infections requiring systemic treatment; 10. Have a history of hypersensitivity to any active or inactive ingredients of Ametinib or to drugs with similar chemical structure to Ametinib or the same class of Ametinib; 11. Any serious or uncontrolled eye disease may increase the safety risk of the patient as judged by the doctor; 12. Patients who are judged by the investigator who may not comply well with the procedures and requirements of the study; 13. The investigator judges that there are any patients with co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Total lifetime;Objective remission rate;Disease Control Rate;Duration of remission;Depth of tumor remission; | — |
Countries
China
Contacts
Public ContactLu Shun
Shanghai Chest Hospital
Outcome results
None listed