A prospective observational study of osimertinib as predictive marker against patients with EGFR mutation positive NSCLC.

A prospective observational study of osimertinib as predictive marker against patients with EGFR mutation positive NSCLC. - A prospective observational study of osimertinib as predictive marker against patients with EGFR mutation positive NSCLC.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040432

Enrollment

Registered

2020-06-01

Start date

2018-09-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically confirmation of non small cell lung cancer 2) EGFR gene mutation has been examined and administration of osimertinib is planned 3) ECOG-PS 0-2 4) Adequate organ functions 5) Expected survival over 12 weeks 6) Written informed consent

Exclusion criteria

Exclusion criteria: 1)Active double cancer 2)Interstitial pneumonitis on chest CT 3)Active infectious disease 4) Not approbed for blood sampling 5) Plegnant woman

Design outcomes

Primary

Measure	Time frame
Primary endpoint:To predict the efficacy of osimertinib according to quantitative amount ofEGFR mutation expression. Secandary endpoint:To predict the efficacy of osimertinib according to quantitative amount of C797S.	—

Countries

Japan

Contacts

Public ContactNorimitsu Kasahara

Gunma University Hospital Innovative Medical Center

m14702016@gunma-u.ac.jp027-220-8222

Outcome results