A Retrospective Study About Treatment Strategy After First/Second Line EGFR-TKI Failure

Which Treatment Strategy is Best in Non-small Cell Lung Cancer Patients Harboring EGFR Mutant Type After First/Second Line EGFR-TKI Failure, a Retrospective Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02618590

Enrollment

800

Registered

2015-12-01

Start date

2015-06-30

Completion date

2016-12-31

Last updated

2016-03-16

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

Keywords

non-small cell lung cancer, EGFR mutant type, first/second line EGFR-TKI

Brief summary

This is a multi-center retrospective study, designing to access the best treatment strategy in non-small cell lung cancer (NSCLC) patients harboring EGFR mutant type after first/second line EGFR-TKI failure. The study end point is Progression Free Survival 2 (PFS2), which is defined as the time period from Progression Disease 1(PD1) to Progression Disease 2(PD2). PD1 is defined as the first tumor progression time from taking EGFR-TKI evaluated by Recist 1.1 criterion, and PD2 as the second tumor progression time after EGFR-TKI failure no matter what second/third line treatment was, PD2 is also evaluated by Recist 1.1 criterion.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients who was confirmed stage IV (according to International Association for the Study of Lung Cancer（IASLC） TNM staging, 2009) non-small cell lung cancer (NSCLC) by histology or cytology between year 2009 to 2013, harboring EGFR mutant type (19 and/or 21 exon mutation). * Appraisable disease, that is there must be at least one lesion with the longest diameter\>10mm according to Recist 1.1 criterion (by contrast CT). * Patients who take EGFR-TKI as first/second line therapy.

Exclusion criteria

* Patients who has taken EGFR-TKI before. * Patients who take EGFR-TKI as third or more line. * Patients who take EGFR-TKI concurrent with chemotherapy or other anti-tumor drug. * The evaluated lesions has treated with radiotherapy before or concurrent with EGFR-TKI. * Patients whose EGFR expression is positive by immunochemical and/or EGFR amplification is positive by Fluorescence In Situ Hybridization(FISH), without mutation detection evidence.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival 2 (PFS2)	6 months

Secondary

Measure	Time frame
overall survival (OS)	3 year

Countries

China

Contacts

Primary Contactli-kun Chen

chenlk@sysucc.org.cn020-87342475

Outcome results