An observational study of serum and cerebrospinal fluid concentrations of osimertinib for the treatment of lung cancer harboring EGFR activating and T790M mutations.

An observational study of serum and cerebrospinal fluid concentrations of osimertinib for the treatment of lung cancer harboring EGFR activating and T790M mutations. - An observational study of serum and cerebrospinal fluid concentrations of osimertinib.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000024327

Enrollment

Registered

2016-10-17

Start date

2016-10-10

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. Histologically or cytologically documented non-small cell lung cancer. 2. Stage IIIB or stage IV or recurrent NSCLC. 3. Detected EGFR activating mutation (exon 19 deletion or exon 21 L858R) by highly sensitive PCR methods. 4. Have a history of first or second generation EGFR-TKI treatment. 5. Detected T790M mutation by highly sensitive PCR methods. 6. Patients who have at least one or more measurable lesion by RESIST (Version1.1) 7. Performance status (ECOG) 0-2 8. Estimated life expectancy at least 3 months. 9. Adequate organ function for osimertinib treatment 10. Written informed concent. 11. Aged over 20 years.

Exclusion criteria

Exclusion criteria: 1. Having an evidence of ILD or pulmonary fibrosis complication on chest X-ray. 2. With severe complication. 1)Uncontrollable angina pectoris, myocardial infarction, or heart failure. 2)Uncontrollable diabetes or hypertension. 3)Severe infectious disease. 4)gastrointestinal dysfunction with severe diarrhea. 3. Impossible to take drugs orally. 4. Inadequate case considered from drug package insert of osimertinib.

Design outcomes

Primary

Measure	Time frame
To evaluate the relationship of serum osimertinib concentration and toxicity	—

Secondary

Measure	Time frame
1)To evaluate the relationship of serum osimertinib concentration and efficacy. 2)To evaluate the relationships of CSF concentration of osimertinib and CNS toxicity. 3)To cleat the pharmacogenomics of osimertinib.	—

Countries

Japan

Contacts

Public ContactTatsuro Fukuhara

Miyagi Cancer Center Department of respiratory medicine

fukuhara-tatsuro@miyagi-pho.jp022-384-3151

Outcome results