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

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.

Study Overview

• Status: Unknown
• Conditions: Non-Small Cell Lung Cancer

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-sen University of Cancer Center
      • Contact: li-kun chen, doctor; Phone Number: 13798019964

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who were diagnosed with stage IV non-small cell lung cancer (NSCLC) harboring EGFR mutant type (19 and/or 21 exon mutation), and took EGFR-TKI as first/second line therapy.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival 2 (PFS2)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival (OS)	3 year

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: li-kun Chen, doctor, associate chief physician

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 22, 2015
• First Submitted That Met QC Criteria: November 29, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; EGFR mutant type; first/second line EGFR-TKI
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2015-FXY-029-内科