Predictive Impact of PD-L1 expression for anti-tumor activity of osimertinib in patients with T790M mutated non-small cell lung cancer

Not Applicable

• Conditions: non-small cell lung cancer harboring EGFR-T790M mutation after treatment with EGFR-TKI

• Registration Number: JPRN-UMIN000026818
• Lead Sponsor: 2nd division, Department of internal medicine, Hamamatsu University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-19
• Study Completion: 2021-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine an association between PD-L1 expression in re-biopsied samples and progression free survival with osimertinib

Secondary Outcome Measures

Name	Time	Method
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