An observational study of EGFR mutation status by circulating tumor DNA during the osimertinib treatment of lung cancer harboring EGFR activating and T790M mutations.

An observational study of EGFR mutation status by circulating tumor DNA during the osimertinib treatment of lung cancer harboring EGFR activating and T790M mutations. - An observational study of plasma EGFR mutation status during osimertinib treatment.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000025278

Enrollment

Registered

2016-12-20

Start date

2016-10-05

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. Regarding the patients who have be treated with radiotherapy; 1) Not have received radiotherapy to lesions of lung. 2) More than 12 weeks after receiving radiotherapy to bone metastases in thoracic lesion. 3) More than 2 weeks after receiving radiotherapy to lesions except lung. 7. Regarding the patients who have be treated with therapy as follows; 1) More than 4 weeks after the last operation 2) More than 2 weeks after the last drainage of the pleural space. 3) More than 2 weeks after the last pleurodesis except anticancer drugs 4) More than 3 weeks after the last cytotoxic chemotherapy. 8. Patients who have at least one or more measurable lesion by RESIST (Version1.1) 9. Performance status (ECOG) 0-2 10. Estimated life expectancy at least 3 months. 11. Adequate organ function for osimertinib treatment 12. Written informed consent. 13. Aged over 20 years.

Exclusion criteria

Exclusion criteria: 1. Having an evidence of ILD or pulmonary fibrosis complication on chest X-ray. 2. Having a history or serious complications as bellows: 1) uncontrollable angina pectoris, cardial infarction within 3 months before enrollment, 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
The occurrence ratio of plasma C797S mutations in all osimertinib resistant cases.	—

Secondary

Measure	Time frame
The interval between plasma C797S emerged time and the time of confirmed RECIST PD.	—

Countries

Japan

Contacts

Public ContactTatsuro Fukuhara

Miyagi Cancer Center Department of respiratory medicine

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

Outcome results