Ultra-sensitive detection of the T790M mutation using droplet digital PCR and, efficacy and resistance analysis of EGFR tyrosine kinase inhibitors in pretreatment non-small cell lung cancer patients with EGFR mutation.

Ultra-sensitive detection of the T790M mutation using droplet digital PCR and, efficacy and resistance analysis of EGFR tyrosine kinase inhibitors in pretreatment non-small cell lung cancer patients with EGFR mutation. - Ultra-sensitive detection of the T790M mutation using droplet digital PCR and, efficacy and resistance analysis of EGFR tyrosine kinase inhibitors in pretreatment non-small cell lung cancer patients with EGFR mutation.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000027592

Enrollment

Registered

2017-06-01

Start date

2017-03-13

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: [Subject I] 1)Histologically and/or cytologically proven non-small cell lung cancer 2)Locally advanced or metastatic disease 3)EGFR mutation positive (deletion19 or L858R) 4)Start EGFR tyrosine kinase inhibitor treatment as first line therapy from August 2013 to July 2016 5)Have signed an informed consent document [Subject II] 1)In subject I cases, patients who performed rebiopsy until Descember 2016 2)Have signed an informed consent

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
The association between the quantity of T790M copies and progression free survival of EGFR tyrosine kinase inhibitor treatment	—

Secondary

Measure	Time frame
The association between the quantity of T790M copies and response rate or overall survival The association between efficacy of EGFR tyrosine kinase inhibitor mutations such as CTNNB1 and MET amplification Compare T790M detection using Cobas V2.0 and degital droplet PCR	—

Countries

Japan

Contacts

Public ContactKenji Sawa

Osaka City University Graduate School of Medicine Department of Respiratory Medicine

sawa.kenji@med.osaka-cu.ac.jp06-6645-3793

Outcome results