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

Not Applicable

• Conditions: lung Cancer

• Registration Number: JPRN-UMIN000025278
• Lead Sponsor: Miyagi Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-20
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence ratio of plasma C797S mutations in all osimertinib resistant cases.

Secondary Outcome Measures

Name	Time	Method
The interval between plasma C797S emerged time and the time of confirmed RECIST PD.