Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)

Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study) - Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033969

Enrollment

Registered

2018-08-31

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

Non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Scheduled for osimertinib therapy (80mg/day, daily) 2)To collect an additional 17mL blood before osimertinib therapy is acceptable 3)FFPE tissue sample before afatinib or gefitinib therapy is available 4)Confirmed T790M acquisition at disease progression at 1st line afatinib or gefitinib therapy 5)FFPE tissue sample at the time of disease progression to afatinib or gefitinib therapy is available 6)ECOG performance status: 0 to 2 7)Life expectancy longer than 3 months 8)Adequate organ functions 9)Written informed consent 10)Age >=20 years and <70 years

Exclusion criteria

Exclusion criteria: 1)Administrated other EGFR-TKI before afatinib or gefitinib treatment as 1st line therapy 2)Administrated afatinib or gefitinib as 1st line therapy and recieved other anti-tumor medicine after disease progression before prior to osimertinib therapy 3)Interstitial lung disease or pulmonary fibrosis 4)Active double cancers 5)Uncontrolled abdominal or pericardial effusion or ascites 6)With the following severe comorbidities -Uncontrolled angina, cardiac infarct within three month, or heart failure -Uncontrolled diabetes or hypertension -Severe infection or comorbidities -Significant or recent gastrointestinal disorders whose main symptom is diarrhea -Other complications (e.g. ileus) judged to pose serious obstacles to osimeltinib therapy 7)Women who are pregnant, planning to become pregnant, or breast-feeding. Patients who are unwilling to use contraceptives 8)Patients whose physician assessed inappropriate to the study

Design outcomes

Primary

Measure	Time frame
The change in clonal heterogeneity upon afatinib or gefinitib treatment.	—

Secondary

Measure	Time frame
The correlation of the clonal heterogeneity with the efficacy of osimertinib.	—

Countries

Japan

Contacts

Public ContactYoshihiro Hattori

Hyogo Cancer Center Department of Thoracic Oncology

hattori@hp.pref.hyogo.jp078-929-1151

Outcome results