Non-small cell lung cancer
Conditions
Interventions
30mg/d:Take medicine on an empty stomach once a day
60mg/d:Take medicine on an empty stomach once a day
120mg/d:Take medicine on an empty stomach once a day
180mg/d:Take medicine on an empty stomach once a day
240mg/d:Take medicine on an empty stomach once a day
300mg/d:Take medicine on an empty stomach once a day
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have a full understanding of this study and have voluntarily signed the informed consent; 2. Age: 18~75 years old male or female patients; 3. Locally advanced or metastatic NSCLC patients with EGFR mutations confirmed histologically or cytologically and with T790M positive mutations confirmed by blood/tumor tissues; 4. According to the ECOG standards, physical fitness is 0-1 and has not deteriorated in the previous 2 weeks, and the expected survival time is >= 3 months; 5. Locally advanced or metastatic NSCLC patients who have relapsed or progressed after egFR-TKI treatment but are not suitable for surgery or radiotherapy, failed conventional treatment; 6. There must be at least one measurable lesion (RECIST V1.1) that can be a lung lesion or metastatic lesion in other parts of the body without radiotherapy; 7. Women of childbearing age subjects appropriate contraception measures must be taken (including not limited to: hormonal contraceptives, or physical contraception, or abstinence), can't breastfeed, if there is a potential pregnancy may, before starting the treatment must have a negative pregnancy test results, or one of the conditions must meet the following criteria to prove that there is no potential of pregnancy may be: A. Menopause is defined as an age over 50 years of age and at least 12 months after discontinuation of exogenous hormone therapy; B. There is documented irreversible surgical sterilization, which may be hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation; C. For subjects younger than 50 years of age, the following conditions can be considered menopause: at least 12 months after discontinuation of exogenous hormone therapy, and serum FSH and LH levels in the postmenopausal range; 8. Male subjects must be willing to use barrier contraception (e.g., condoms) and contraceptive methods must be used up to 3 months after the last experimental drug administration.
Exclusion criteria
Exclusion criteria: 1. Have taken other drugs in clinical trials within 30 days prior to the first administration; 2. EGFR TKI was administered within 8 days prior to the first administration of the trial or 5 times the half-life of the drug (in both cases the longer term). If the clearance time for this EGFR TKI cannot be achieved due to timing or pharmacokinetic characteristics, an alternative clearance time may be proposed based on the known recovery time for drug-related side effects, subject to the consent of the investigator and the sponsor; 3. Prior treatment regimen including any cytotoxic chemotherapy or other anticancer drugs for advanced non-small cell lung cancer within 14 days prior to the first administration of the trial; 4. Major surgical operation (other than placement of an indwelling needle) or major trauma within 4 weeks prior to the first administration of the trial, or major surgery is expected to be required during the trial; 5. Received local small area palliative radiotherapy within 1 week prior to the first administration of the trial (for subjects requiring more than 30% bone marrow radiotherapy, this radiotherapy must be completed 4 weeks prior to the first administration); 6. Patients with spinal cord compression or brain or meningeal metastasis, except for those who are asymptomatic, stable or do not require steroid treatment for at least 4 weeks prior to first administration; 7. The patients are taking (or should not stop taking at least 1 week before the first administration of the trial) any drug or traditional Chinese medicine that is known to inhibit or induce CYP3A4 activity, see Appendix 13.3 for details; 8. Allergic to YZJ-0318 maleate and its structural analogues or its pharmaceutical excipients (whether or not active); 9. Subjects who had received EGFR TKI III (including AZD9291) or were screened for AZD9291 by plasma drugs; 10. An adverse event greater than CTCAE level 1 that was not in remission due to prior treatment at the start of this trial, excluding alopecia; 11. Criteria for any of the following heart diseases: (1) QT interval (QTcF) value > 470 ms (Corrected by the Fridericia formula); (2) Any clinically significant cardiac rhythm abnormalities, resting ECG conduction and morphological abnormalities, such as complete left bundle branch block, type II II and type III atrioventricular block; (3) Any factors that increase the risk of QT prolongation and arrhythmia, such as familial QT prolongation, a history of medically induced arrhythmia, etc.; (4) Left ventricular ejection fraction (LVEF) 2.5 x ULN; (5) If there is concurrent liver metastasis, ALT or AST > 5 x ULN; (6) If there is no verifiable liver metastasis, total bilirubin 1.5 x ULN, in case of liver metastasis or Gilbert syndrome, total bilirubin > 3 x ULN. (7) With creatinine clearance rate 1.5 x ULN. Only if creatinine Creatinine clearance was confirmed at 1.5 x ULN. 13. Uncontrolled diabetes after treatment (HbA1C > 7.0%). 14. A prior history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic characteristics of PLASMA YZJ-0318;The type and content of metabolites;ORR;DCR;DOR;Changes in tumor size relative to baseline;PFS; | — |
Countries
China
Contacts
Public ContactTaotao Jiang
Outcome results
None listed