Prospective study for clarification of mechanisms of acquired resistance for afatinib using plasma samples

Prospective study for clarification of mechanisms of acquired resistance for afatinib using plasma samples - Study for acquired resistance mechanisms for afatinib using plasma samples

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026108

Enrollment

Registered

2017-02-13

Start date

2017-02-20

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: 1. StageIIIB or IV non-small cell lung cancer patients with EGFR activating mutations such as exon 19 deletion, L858R, L861Q and G719X. 2. Patient is treated with afatinib as the first line therapy. 3. Non-small cell lung cancer patients with lesions which can be evaluated by RECIST (Version 1.1). 4. Patients with non-small-cell lung cancer (NSCLC) confirmed histologically or cytologically. 5. Non-small cell lung cancer patients with written consent.

Exclusion criteria

Exclusion criteria: 1. Previously treated with an EGFR TKI. 2. Previously treated with an immune checkpoint inhibitor. 3. Patients who, in the opinion of the attending physician, are inappropriate for the study .

Design outcomes

Primary

Measure	Time frame
Examination of variety and rate of gene abnormality detected from plasma at the time of acquired resistance for afatinib.	—

Secondary

Measure	Time frame
Examination of variety and rate of gene abnormality detected from ctDNA before and at the time of acquired resistance for afatinib. Examination about correlation of gene abnormality detected from ctDNA and response rate, progression free survival and time to treatment.	—

Countries

Japan

Contacts

Public ContactTomomi Nakamura

Saga Univ, Faculty of Medicine Division of Hematology, Respiratory Medicine and Oncology

nakamurt@cc.saga-u.ac.jp0952-34-2369

Outcome results