Advanced Non-Small Cell Lung Cancer
Conditions
Interventions
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 between18 and 80 Years on the day of signing the informed consentMale or Female; 3. NSCLC diagnosed histologically or cytologically with pathological stage IIIB or IV; 4. Be EGFR mutations (e.g. exon 19 deletion and 21 mutation) with EGFR-TKI sensitivity, at any time after the initial diagnosis; 5. At least one unidimensional measurable lesion (as per RECIST criteria); 6. ECOG performance status 0-1; 7. Life expectancy more than 3 months; 8. Have adequate organ function: Neutrophils >=1.5 x10^9/L, Platelets >=100x10^9/L, Hemoglobin >=90 g/L; 9. Total bilirubin =60 mL/min (estimated according to Cockcroft-Gault formula); 11. INR<=1.5; 12. 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. Has received EGFR-TKI (such as Erlotinib, Gefitinib, Ectinib); 2. Has received major surgery, radiotherapy and chemotherapy, immunotherapy or antineoplastic treatments (including angiogenesis inhibitors, molecular targeting inhibitors, etc.) within 14 days prior to the informed consent. Or all treatment-related toxicities in level 2 or higher (according to NCI-CTCAE criteria version 4.03) caused by previous antineoplastic treatments. 3. Long-term use of adrenal steroid hormone (equivalent to prednisolone daily dose >=20 mg); 4. Dysphagia or participants may be malabsorption in the investigators opinion; 5. 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; 6. 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; 7. Women are pregnant or breast-feeding; 8. Participants with active or uncontrolled systemic disease/infection, such as HBV, HCV (except normal liver function) and HIV; 9. Other uncontrolled comorbidities include, but are not limited to, infectious or active infections, mental illness, or other social factors that limit adherence to the program; 10. Researchers consider it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;TTP; | — |
Countries
China
Contacts
Public ContactKai Wang
the Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed