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

NCT02618590 | Unknown DMC

• 1 other identifier: 2015-FXY-029-内科
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival 2 (PFS2)

  6 months

Secondary Outcomes (1)

• overall survival (OS)

  3 year

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University of cancer center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• li-kun Chen, doctor

  associate chief physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

li-kun Chen

CONTACT

020-87342475; chenlk@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor/Associate chief physician

Study Record Dates

• First Submitted: August 22, 2015
• First Posted: December 1, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

CN (1)