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 between 18 and 80 years on the day of signing the informed consent, Male or Female; 3. NSCLC diagnosed histologically or cytologically with pathological stage IIIB or IV; 4. Previous usage of approved EGFR-TKI (such as Erlotinib, Gefitinib, Ectinib or Afatinib) with the imaging evidence of disease progression; 5. Be EGFR mutations (e.g. exon 19 deletion and 21 mutation,L858R,L861Q,G719X,and S768I) with EGFR-TKI sensitivity, at any time after the initial diagnosis. 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; 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. Has received EGFR-TKI (such as Erlotinib, Gefitinib, Ectinib or Afatinib) within 8 days or 5 half-lives prior to the first dose of study treatment; 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. Participants who have taken second or third generation EGFR-TKI for more than two weeks before enrollment; 5. Dysphagia or participants may be malabsorption in the investigators opinion; 6. 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; 7. 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; 8. Women are pregnant or breast-feeding; 9. Participants with active or uncontrolled systemic disease/infection, such as HBV, HCV (except normal liver function) and HIV; 10. Other uncontrolled comorbidities, including but not limited to, infection or active infection, mental illness, or other social factors that limit compliance with the program; 11. Participants have any condition which, in the investigators opinion, makes the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;PFS;TTP; | — |
Countries
China
Contacts
Public ContactKai Wang
the Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed