Real world molecular testing among patients with EGFR mutation positive NSCLC following progression on an EGFR-TKI in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000024928

Enrollment

300

Registered

2016-11-24

Start date

2016-11-25

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.Age more than 20 y.o. 2.Able to obtain Informed Consent Form 3.Diagnosed advanced non-small cell lung cancer with EGFR mutation 4.Investigator judged "Disease Progress" during EGFR-TKI treatment.

Exclusion criteria

Exclusion criteria: 1.Patients who the investigator judged retrospective review of medical charts or information on pre-progression medical history at the participating site cannot be done. 2.Patients already given T790M targeting EGFR-TKI 3.Patients having EGFR-TKI treatment with more than two different TKIs, except EGFR-TKI switching patients with toxicity reason

Design outcomes

Primary

Measure	Time frame
?Re-biopsy ratio among the patients who had disease progression during EGFR-TKI treatment : All, by kind of sample ?The kind of sample for re-biopsy and the reason why its sample is selected. ?The mutation assay pattern to decide which treatment for next line: sample / assay method. ?The reason why re-biopsy is not performed	—

Secondary

Measure	Time frame
?Timing to conduct re-biopsy and its status; the lesion at biopsy, biopsy method (e.g. core needle, FNA, excisional biopsy) and success rate of re-biopsy by samples. ?Occurrence of complications at re-biopsy, type of complications and its outcome. ?Kind of treatment and its duration till PD ?A site of recurrence after EGFR-TKI therapy ?Subsequent treatment pattern after re-biopsy (e.g., chemotherapy/targeted therapy used, palliative care, starting time of the next treatment line) by availability of re-biopsy and T790M testing, and/or by T790M testing outcome ?T790M prevalence among previous EGFR-TKI treatments and EGFR mutation sub-type at diagnosis ?In case other treatment is conducted after judgement of PD prior to re-biopsy [beyond PD, radiation therapy, et al], the detailed information of the treatment (method, timing, period)	—

Measure

Time frame

?Timing to conduct re-biopsy and its status; the lesion at biopsy, biopsy method (e.g. core needle, FNA, excisional biopsy) and success rate of re-biopsy by samples. ?Occurrence of complications at re-biopsy, type of complications and its outcome. ?Kind of treatment and its duration till PD ?A site of recurrence after EGFR-TKI therapy ?Subsequent treatment pattern after re-biopsy (e.g., chemotherapy/targeted therapy used, palliative care, starting time of the next treatment line) by availability of re-biopsy and T790M testing, and/or by T790M testing outcome ?T790M prevalence among previous EGFR-TKI treatments and EGFR mutation sub-type at diagnosis ?In case other treatment is conducted after judgement of PD prior to re-biopsy [beyond PD, radiation therapy, et al], the detailed information of the treatment (method, timing, period)

—

Countries

Japan

Outcome results