Advanced Non-Small Cell Lung Cancer
Conditions
Interventions
cohort 1:Oral 60mg once a day
cohort 2:Oral 80mg once a day
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Signing informed consent form; 2. Aged between 18 and 80 years on the day(Include boundary values), Male or Female; 3. Advanced or locally advanced non-small cell lung cancer diagnosed by histology or cytology with pathological stage IIIB or IV, which is not suitable for radical surgery and radical radiotherapy; 4. Have not receive any systemic antitumor treatment (except neoadjuvant or adjuvant chemotherapy); 5. Carry EGFR mutations (Del 19,L858R) ; 6. At least one unidimensional measurable lesion (as per RECIST criteria); 7. ECOG performance status 0-1; 8. Life expectancy more than 3 months; 9. Have adequate organ function: Neutrophils >=1.5 x10^9/L, Platelets >=100 x10^9/L, Hemoglobin >=90 g/L; 10. Total bilirubin =60 mL/min (estimated according to Cockcroft-Gault formula); 12. INR<=1.5; 13. Participants - both males and females - with reproductive potential must practice effective contraceptive measures through 30 days after the last dose of all study treatments. Women of child-bearing potential must provide a negative pregnancy test within 7 days prior to the first dose of treatment. Men were not allowed to sperm donation within 90 days after the last dose of all study treatments.
Exclusion criteria
Exclusion criteria: 1. Combined with other lung cancer driver gene mutations, such as; ALK, BRAF, ERBB2, KRAS, KRAS, MET, RET, ROS1; 2. Participants with prior any following treatments: previous systemic anti-tumor treatment (except neoadjuvant or adjuvant chemotherapy); more than 30% of bone marrow radiotherapy, or extensive irradiation in the 4 weeks prior to the first dose of study treatment (Except for palliative radiotherapy only for the relief of pain in non-target lesions, etc.); other antitumor therapies, including molecular targeted therapy (such as EGFR TKI, angiogenesis inhibitors, etc.), immunotherapy (such as cellular immunotherapy anti-PD-1 Or anti-PD-L1), other experimental drug treatments; 3. Major surgery performed within four weeks of first study drug administration; 4. Drugs or herbal supplements that the participant is using (or cannot be discontinued within 1 week prior to the first dose of study treatment), known to be strong inducers of cytochrome P450 (CYP450) 3A4; 5. Long-term use of adrenal steroid hormone within 4 weeks (equivalent to prednisolone daily dose >=20 mg); 6. Dysphagia or participants may be malabsorption in the investigators opinion; 7. Participants have other primary tumors; exceptions include cured basal cell carcinoma or squamous cell carcinoma of the skin, cervical carcinoma in situ; or the malignancy is progression-free within the past 5 years; 8. participants with brain metastases, except for the following:1) the largest lesion diameter is less than 2cm and no obvious clinical symptoms;2) the brain metastases have been controlled and stable for more than 4 weeks 9. Resting ECG has significant clinically significant abnormalities in rhythm, conduction, and morphology, such as complete left bundle branch block, cardiac block above II degree, PR interval> 250 ms; myocardial infarction occurred within 6 months; There are risk factors that lead to prolonged QT interval or increased risk of arrhythmia, such as heart failure, moderate or severe hypokalemia, diagnosed or suspected congenital long QT syndrome, family history of long QT syndrome or first-degree relatives with a history of sudden death less than 40 years of age; Mean of 3 times of ECG Fridericia-corrected QT intervals (QTcF): male> 450 ms, female> 470 ms; 10. Women are pregnant or breast-feeding; 11. Participants with active or uncontrolled systemic disease/infection, such as HBV(HBsAg positive, HBV-DNA> 1000cps/ml and AST / ALT> 2.0xULN), HCV (except normal liver function) and HIV; 12. Other uncontrolled comorbidities, including but not limited to, infection or active infection; 13. Participants with history of epilepsy, mental illness, or other social factors that limit compliance with the program; 14. Participants have any condition which, in the investigators opinion, makes the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;TTP;DoR;OS; | — |
Countries
China
Contacts
Public ContactKai Wang
the Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed