non-small cell lung cancer harboring EGFR-T790M mutation after treatment with EGFR-TKI
Conditions
Interventions
None listed
Sponsors
2nd division, Department of internal medicine, Hamamatsu University School of Medicine
Seirei Mikatahara General Hospital National Hospital Organization Tenryu Hospital Hamamatsu Red Cross Hospital Hamamatsu Rosai Hospital JA Shizuoka Kohseiren Enshu Hospital Iwata city Hospital Shizuoka General Hospital Shizuoka City Shimizu Hospital Shizuoka City Shizuoka Hospital Shizuoka Saiseikai General Hospital Fujieda Municipal General Hospital Hamamatsu Medical Center Shizuoka Red Cross Hospital Seirei Hamamatsu General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically proven, incurable NSCLC at Stage IIIB or IV 2. Previously treated with EGFR-TKI 3. EGFR-T790M is confirmed by re-biopsy which is performed in clinical practice 4. Patients who will receive osimertinib at 80mg/day 5. Have tissue samples which are evaluable for IHC 6. 20 years or older 7. ECOG-PS 0-2 8. Have signed an informed consent document
Exclusion criteria
Exclusion criteria: 1. Previously treated with osimertinib 2. Previously treated with PD-1/PD-L1 antibody 3. Receiving rifampicin or carbamazepine or St. John's wort and cannot stop. 4. Presence of other active malignancies 5. Pregnant, or have possibility of pregnant, or breast feeding 6. Presence of or have previous history of interstitial lung disease 7. With severe complication which could interfere 8. With active infection including HIV or HBV 9. Unable to have medication per oral 10. Have a history of hypersensitivity with osimeritinib 11. Considered as inadequate for enrollment by primary physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine an association between PD-L1 expression in re-biopsied samples and progression free survival with osimertinib | — |
Secondary
| Measure | Time frame |
|---|---|
| To explore an association between PD-L1/PD-L2 expression and efficacy of osimertinib To explore an alteration of PD-L1/L2 expression and CD3 cell infiltration after EGFR-TKI treatment | — |
Countries
Japan
Contacts
Public ContactNorimichi Akiyama
Hamamatsu University School of Meidicne 2nd division, Department of Internal Medicine
Outcome results
None listed