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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No