Real world molecular testing among patients with EGFR mutation positive NSCLC following progression on an EGFR-TKI in Japa
Not Applicable
- Conditions
- on small cell lung cancer
- Registration Number
- JPRN-UMIN000024928
- Lead Sponsor
- AstraZeneca K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 300
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?Re-biopsy ratio among the patients who had disease progression during EGFR-TKI treatment : All, by kind of sample<br><br>?The kind of sample for re-biopsy and the reason why its sample is selected.<br><br>?The mutation assay pattern to decide which treatment for next line: sample / assay method. <br><br>?The reason why re-biopsy is not performed
- Secondary Outcome Measures
Name Time Method ?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.<br><br>?Occurrence of complications at re-biopsy, type of complications and its outcome. <br><br>?Kind of treatment and its duration till PD<br><br>?A site of recurrence after EGFR-TKI therapy<br><br>?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<br><br>?T790M prevalence among previous EGFR-TKI treatments and EGFR mutation sub-type at diagnosis<br><br>?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)