A prospective observational study of osimertinib as predictive marker against patients with EGFR T790M-positive NSCLC.

A prospective observational study of osimertinib as predictive marker against patients with EGFR T790M-positive NSCLC. - Osimertinib as predictive marker in T790M-positive NSCLC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000027233

Enrollment

Registered

2017-05-06

Start date

2017-05-01

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 with T790M has been examined 3) Administration of osimertinib is planned or ongoing 4) Aged 20 or more 5) Expected survival over 12 weeks 6) Adequate organ functions 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1)Active double cancer 2)Interstitial pneumonitis on chest CT 3)Symptomatic brain metastases 4)Uncontrollable pleural effusion or pericardial effusion 5)Active infectious disease 6)No allogeneic bone marrow transplant

Design outcomes

Primary

Measure	Time frame
Primary endpoint:To predict the efficacy of osimertinib according to quantitative amount of T790M expression. Secandary endpoint:To predict the efficacy of osimertinib according to quantitative amount of C797S.	—

Countries

Japan

Contacts

Public ContactKyoichi Kaira

Gunma University Hospital Innovative Medical Center

kkaira1970@yahoo.co.jp027-220-8222

Outcome results