Analysis of response and acquired resistance to EGFR-TKI by multiple circulating tumor DNA with cancer-specific gene mutations

Analysis of response and acquired resistance to EGFR-TKI by multiple circulating tumor DNA with cancer-specific gene mutations - Analysis of response and acquired resistance to EGFR-TKI by multiple circulating tumor DNA with cancer-specific gene mutations

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028990

Enrollment

Registered

2017-09-10

Start date

2017-10-01

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

Non-small cell lung cancer

Interventions

Blood examination

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: I.Patients with histologically or cytologically confirmed EGFR-mutant (Ex19 deletion or L858R) NSCLC II.Patients who are planning to receive Osimertinib. III.Sufficient functions of the main organs IV.PS 0-2 at the start of the treatment with Osimertinib V.Submission of written informed consent concerning study participation

Exclusion criteria

Exclusion criteria: Patients judged by the investigator to be unsuitable for the study

Design outcomes

Primary

Measure	Time frame
1) The rate at which the marker ctDNA is determined in the patients with EGFR-mutant NSCLC 2) Time course of the marker ctDNA change during Osimertinib treatment 3) Comparison of the mutations including T790M and C797S between cancer tissue DNA and ctDNA 4) Comparison of the allelic frequency (AF) of the mutations between cancer tissue DNA and ctDNA 5) Correlation between radiologic response to Osimertinib and AF in cancer tissue DNA and ctDNA at the start of the treatment with Osimertinib 6) Time course of ctDNA during Osimertinib treatment and resistance mechanism to Osimertinib in view of ctDNA	—

Measure

Time frame

1) The rate at which the marker ctDNA is determined in the patients with EGFR-mutant NSCLC 2) Time course of the marker ctDNA change during Osimertinib treatment 3) Comparison of the mutations including T790M and C797S between cancer tissue DNA and ctDNA 4) Comparison of the allelic frequency (AF) of the mutations between cancer tissue DNA and ctDNA 5) Correlation between radiologic response to Osimertinib and AF in cancer tissue DNA and ctDNA at the start of the treatment with Osimertinib 6) Time course of ctDNA during Osimertinib treatment and resistance mechanism to Osimertinib in view of ctDNA

—

Countries

Japan

Contacts

Public ContactFumio Imamura

Osaka International Cancer Institute Department of Thoracic Oncology

imamura-fu@mc.pref.osaka.jp+81-6-6945-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026