AZD9291 in EGFR exon 20 insertion mutations
- Conditions
- on-Small cell Lung Cancer harbouring EGFR exon 20 insertion mutations
- Registration Number
- JPRN-UMIN000031929
- Lead Sponsor
- Keio University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 21
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method progression free survival, PFS overall survival safety