Non-Small cell Lung Cancer harbouring EGFR exon 20 insertion mutations
Conditions
Interventions
Simon'
s two stage design Stage 1 (n=12) Stage 2 (n=9)
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with 20 years or older 2. Patient with pathologically confirmed non-small cell lung cancer(NSCLC) 3. Patient with advanced or metastatic NSCLC harbouring with EGFR exon 20 insertion mutation. Patient with incurable NSCLC by operation or radiation therapy. 4. Patient with NSCLC previously treated with 1, 2 or 3 regimens chemotherapy. 5. Patient with ECOG-PS 0-1. 6. Patient with life expectancy of 12 weeks or more. 7. Patient who agreed to receive clinical testing necessary for this study. 8. Patient with measurable NSCLC by RECIST (ver 1.1) criteria 9. Patient with written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patient who was previously treated by AZD9291 or other EGFR-TKIs (gefitinib, erlotinib, afatinib). 2. Patient with NSCLC harboring other EGFR mutations (Exon 19 deletions, L858R, T790M, G719X, L861Q). 3. Patient who was previously treated by immuno-checkpoint inhibitors. 4. Patient with past history of other malignancies (not including carcinoma in situ) within five years from day of informed consent. 5. Patient who is under the treatment of medication of other trails. Patient who was treated by other trial medication within five years from informed consent. 6. Patient with uncontrollable hypertension. 7. Patient with uncontrollable diabetes mellitus. 8. Patient with active bleeding diathesis. 9. Patient with the following results at screening. HBs antigen, HBs, HBc, HCV or HIV antibodies positive. (HBs positive and/or HBc positive subjectes can be included if HBs antigen is netagitve.) 10. Patient with active infectious disease. 11. Patient who take CYP3A4 inducing medication or supplements. 12. Patient with previous treatment related CTCAE grade 2 or higher toxicities. 13. Patient with symptomatic brain metastases. 14. Patient with interstitial lung disease (ILD), drug induced ILD or radiation pneumonitis treated by systemic steroid therapy. Patient with active ILD. Etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival, PFS overall survival safety | — |
Countries
Japan
Contacts
Public ContactYoko Ito
Keio University Hospital Clinical and Translational Research Center
Outcome results
None listed