Frequency of T790M Mutation on Circulating Tumor DNA in EGFR-mutated NSCLC Patients With acquired resistance to irreversible EGFR-TKI :a prospective observational study

Frequency of T790M Mutation on Circulating Tumor DNA in EGFR-mutated NSCLC Patients With acquired resistance to irreversible EGFR-TKI :a prospective observational study - Frequency of T790M Mutation on ctDNA in patients with acquired resistance to irreversible EGFR-TKI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000024198

Enrollment

Registered

2016-10-01

Start date

2016-10-01

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

EGFR-mutated Non Small Cell Lung Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Patients whose plasma samples can be submitted 2 Pathologically confirmed Nonsquamous Non Small Cell Lung Cancer 3 Clinical stage 3B, 4, or postoperative recurrence 4 With activating EGFR mutation, Deletion in exon 19 or L858R in exon 21 5 Patients with no treatment of EGFR-TKI and planned to EGFR-TKI treatment 6 Regarding the patients who have be treated with radiotherapy -Not have received radiotherapy to lesions of lung -More than 12 weeks after receiving radiotherapy to Sternal lesions -More than 2 weeks after receiving radiotherapy to lesions except lung 7 Regarding the patients who have been treated with therapy as follows -Surgical procedure, including exploratory thoracotomy, more than 4 weeks -Pleural drainage, more than 2 weeks -Pleurodesis except anticancer drugs, more than 2 weeks -AnticancerDrugs, more than 3 weeks 8 Performance Status (ECOG) 0-2 9 Expecte survival time is more than 3 months 10 With adequate organ function 11 Provided written informed consent 12 Ages 20 years and over

Exclusion criteria

Exclusion criteria: 1 Patients with pre-treatment of EGFR-TKI 2 Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest X-ray 3 Synchronous double or multiple cancer or metachronous double or multiple cancer 4 Uncontrolled pleural, ascites effusion or cardiac effusion 5 Patients with active co-morbidities including severe conditions. -Uncontrollable angina pectoris, myocardial infarction within 3 months, heart failure -Uncontrolled diabetes mellitus, hypertension -Severe infection -Patients whose participation in the trial is judged to be inappropriate by the attending doctor -Any other patients who are regarded as unsuitable for this trial by the attending doctor

Design outcomes

Primary

Measure	Time frame
Frequency of T790M Mutation on ctDNA in patients with acquired resistance to irreversible EGFR-TKI	—

Secondary

Measure	Time frame
Evaluation of the relationship between effect of irreversible EGFR-TKI and T790M mutation status	—

Countries

Japan

Contacts

Public ContactHideyuki Nagakura

Graduate school of medicine, Yokohama city university department of pulmonology

hdng8315@yokohama-cu.ac.jp045-787-2508

Outcome results