Advanced Non-Small Cell Lung Cancer
Conditions
Interventions
cohort 1:10mg qd po.
cohort 2:20mg qd po.
cohort 3:30mg qd po.
cohort 4:45mg qd po.
cohort 5:60mg qd po.
cohort 6:80mg qd po.
cohort 7:105mg qd po.
cohort 8:140mg qd po.
Sponsors
Hangzhou Huadong Medicine Group Pharmaceutical Research Institute Co., Ltd.
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 70 years on the day of signing the informed consent, Male or Female; 3. Participants with advanced non-small cell lung cancer who have failed first-line and second-line systemic therapy; Previous usage of approved EGFR-TKI (such as Erlotinib, Gefitinib, Ectinib or Afatinib) with the imaging evidence of disease progression; 4. No major surgery, radiotherapy and chemotherapy, immunotherapy or antineoplastic treatments (including angiogenesis inhibitors, molecular targeting inhibitors, etc.) within 14 days prior to the informed consent. And all treatment-related toxicities returned to level 1 (according to NCI-CTCAE criteria version 4.03) during the screening period. Has received EGFR-TKI (such as Erlotinib, Gefitinib, Ectinib or Afatinib) over 8 days or 5 half-lives prior to the first dose of study treatment; 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 >=100 x10^9/L, Hemoglobin >=90 g/L; 9. Total bilirubin <=1.5 ULN, ALT and AST <=2.5 ULN (<=5 ULN for patients with documented liver metastases); 10. Serum creatinine <=1.0 ULN, or Creatinine clearance= 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. Without histological or cytological confirmation of NSCLC; 2. Has had 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. 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; 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. Signs or symptoms of brain metastases (unless it is excluded by CT or MRI), participants who have developed brain metastases are not allowed to participate in the study, but participants with brain metastases that have been controlled or asymptomatic may be enrolled (no neurological symptoms after surgical resection or radioactivity progress at least 4 weeks after radiotherapy); 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, including but not limited to, infection or active infection, mental illness, or other social factors that limit compliance with the program; 10. Participants have any condition which, in the investigators opinion, makes the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT&MTD; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;PFS;DCR;TTP; | — |
Countries
China
Contacts
Public ContactKai Wang
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed