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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02618590
• Other study ID #: 2015-FXY-029-??
• Status: Recruiting
• Phase: N/A
• First received: August 22, 2015
• Last updated: March 15, 2016
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Sun Yat-sen University
• Contact: li-kun Chen
• Phone: 020-87342475
• Email: chenlk[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
China	Sun Yat-sen University of cancer center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival 2 (PFS2)		6 months	Yes
Secondary	overall survival (OS)		3 year	No