Study of association between effect of afatinib for EGFR-mutated non-small cell lung cancer and circulating free DNA detected with high sensitive analyses for EGFR mutation.

Study of association between effect of afatinib for EGFR-mutated non-small cell lung cancer and circulating free DNA detected with high sensitive analyses for EGFR mutation. - Analysis of ctDNA and afatinib

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014091

Enrollment

Registered

2014-05-28

Start date

2014-05-23

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

From May 2014 to March 2016

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed non-squamous, non-small cell lung cancer 2.Stage or recurrent disease 3.EGFR mutation (exon 19 deletion,L858R) detected by PNA-LNA PCR clamp method 4.Discontinuation of 1st generation EGFR-TKI due to PD or toxicity 5.Planned treatment with afatinib 6.ECOG performance status (PS) 0 to 2 7.Adequate organ functions 8.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Interstitial pneumonitis or pulmonary fibrosis apparent on chest X-ray 2.Concomitant malignancies

Design outcomes

Primary

Measure	Time frame
detection rate of circulating free DNA from plasma after treatment for 2 months	—

Secondary

Measure	Time frame
association between amount of circulating free DNA and effect of 2nd generation EGFR-TKI (PFS, OS)	—

Countries

Japan

Contacts

Public ContactMakoto Maemondo

Miyagi Cancer Center Respiratory Medicine

maemond-ma693@miyagi-pho.jp022-384-3151

Outcome results

None listed

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