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Investigation on the usefulness of liquid biopsy for tumor-derived circulating DNA in patients with EGFR-mutant NSCLC during and after treatment with EGFR-TKIs

Investigation on the usefulness of liquid biopsy for tumor-derived circulating DNA in patients with EGFR-mutant NSCLC during and after treatment with EGFR-TKIs - JP-CLEAR (Japanese Prospective evaluation of tumor-derived Circulating DNA Liquid biopsy in patients with EGFR-mutant NSCLC during and after Acquired Resistance to EGFR-TKI treatment)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000023248
Enrollment
120
Registered
2016-07-20
Start date
2016-08-10
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

Sponsors

PHRF
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients diagnosed as having advanced or postoperative recurrent NSCLC prior to enrollment 2)Patients diagnosed as carrying activating EGFR mutation by each institution (exon19 deletion, exon 21 L858R mutation, or other minor mutations such as exon 18 G719X) 3)Those being treated without progression, or to be treated with, an EGFR-TKI as anticancer therapy 4)ECOG PS 0-2 5)20 years old over 6)Submitted signed informed consent

Exclusion criteria

Exclusion criteria: 1)Prior treatment with EGFR-TKI 2)HBsAg or HCV-RNA positive Patients 3)HIV positive Patients

Design outcomes

Primary

MeasureTime frame
*The plasma DNA T790M positivity rates by Cobas EGFR Mutation Test in the T790M positive tumors patients. *The plasma DNA T790M positivity rates at each clinical point.

Secondary

MeasureTime frame
*The plasma DNA EGFR Exon 19 deletion or Exon 21 L858 mutation positivety rates in clinical courses *Time from plasma T790 positivity to tissue T790M positivity in the tissue T790M-positive cases *Response Rate and PFS with Osimertinib *Response Rate and PFS with rechallenge of other EGFR-TKIs

Countries

Japan

Contacts

Public ContactAkira Yamao

Public Health Reseach Foundation Comprehensive Support Project for Oncology Research

cspor-lc05@csp.or.jp03-5287-2636

Outcome results

None listed

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