Advanced Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental group:QD po 60mg+250mg
Control group:QD po 250mg+60mg
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine/ Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses; 2. Aged between 18 and 75 years on the day of signing the informed consent, Male or Female; 3. Evidence of histo or cytopathology confirmed, advanced NSCLC. (American Joint Committee on Cancer version 8) 4. treatment-naive pathologically con?rmed stage IIIB or IV adenocarcinoma of the lung with a documented, (Minimum of 6 months disease free interval between completion of systemic therapy and recurrence of NSCLC) 5. with the presence of EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21); 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 >=1.5x10^9/L, Platelets >=100x10^9/L, Hemoglobin >=90 g/L; Total bilirubin ,=1.5 ULN, ALT and AST =60 mL/min (estimated according to Cockcroft-Gault formula); INR<=1.5; 10. 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. With history of brain mets or leptomeningeal mets; 2. prior treatment with an EGFR tyrosine kinase inhibitor (TKI)use any kinds of anti-cancer treatment before,radiotherapy within 4 weeks prior to drug administration (except as relieve pain because of bone metastasis); 3. major surgery within 4 weeks prior to drug administration; 4. use of anti-cancer drug about traditional Chinese medicine or Chinese patent medicine; 5. after randomization, concomitant administration of therapeutic index drugs that are CYP2D6CYP3A4P-gp inhibitor or inducer is prohibited; 6. Long-term use of adrenal steroid hormone (equivalent to prednisolone daily dose >=20 mg); 7. History of or currently suspected interstitial lung disease; 8. Uncontrolled or significant eye disease; 9. Dysphagia or participants may be malabsorption in the investigators opinion; 10. Participants have other primary tumors; exceptions include cured basal cell carcinoma or squamous cell carcinoma of the skin, cervical carcinoma in situ; 11. Uncontrolled or significant cardiovascular disease, including: Prolonged QTc interval on electrocardiogram (ECG); QTc must be less than male>450ms, female>470ms, QTcF=QT/(RR^0.33) ECG indicate clinical significant or clinically relevant cardiovascular abnormalities; myocardial infarction within the last 6 months; any threat can induce congenital long QT syndrome; 12. Uncontrolled pleural effusion; 13. Women are pregnant or breast-feeding; 14. Participants with active or uncontrolled systemic disease/infection, such as HBV, HCV (except normal liver function) and HIV; 15. Other uncontrolled comorbidities, including but not limited to, infection or active infection, mental illness, or other social factors that limit compliance with the program; 16. Participants have any condition which, in the investigators opinion,non-compliance with protocol dictates; 17. 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 |
|---|---|
| OS;PFS;ORR;DoR;DCR;TTP;TTF; | — |
Countries
China
Contacts
Public ContactKai Wang/Caicun Zhou
the Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed