Tailored Second Line Treatment by Epidermal Growth Factor Receptor (EGFR) Mutation in Patients With Advanced Lung Adenocarcinoma
|ClinicalTrials.gov Identifier: NCT00903292|
Recruitment Status : Unknown
Verified May 2009 by National Cheng-Kung University Hospital.
Recruitment status was: Recruiting
First Posted : May 18, 2009
Last Update Posted : May 18, 2009
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: erlotinib (Tarceva) Drug: pemetrexed (Alimta)||Not Applicable|
On the other hand, EGFR TKI (gefitinib or erlotinib) both produced somewhat similar higher response rate (around 25%) in general Taiwan adenocarcinoma NSCLC patients, while the median overall survival time didn't longer than chemotherapy treated patients. A recent prospective study of gefitinib in chemonaive adenocarcinoma NSCLC patients showed that the objective response rate was lower to be only 1.1% among EGFR mutation negative patients.
Since typical EGFR gene mutations (i.e., the deletion of typically five amino acids at codons 746-750 (ELREA) in exon 19 and a leucine-to-arginine mutation at codon 858 (L858R)) are a good predictor for tumor response to tyrosine kinase inhibitor, this present study is to tailor the patient's treatment according to his/her EGFR gene mutation status. Receptor tyrosine kinase inhibitor (erlotinib in this study) will be the suggested second-line drug of recommendation for typical EGFR gene mutation patients, and chemotherapy (pemetrexed in this study) will be the suggested second-line drug of recommendation for EGFR wild type patients.
The aim of this study is to increase the overall tumor response rate to 40% from current treatment outcome (around 25%) by this tailored second line treatment. The further interests of this study include prospectively evaluate the predictivity of EGFR gene mutation to tumor response.
The primary objective of this study is to determine the overall tumor response rate of tailored second line treatment determined by typical EGFR gene mutation in patients with advanced lung adenocarcinoma.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tailored Second Line Treatment by EGFR Mutation in Patients With Advanced Lung Adenocarcinoma|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||April 2010|
|Estimated Study Completion Date :||December 2010|
U.S. FDA Resources
Active Comparator: A, erlotinib
If EGFR mutation found then assigned to thyrosine kinase inhibitor (erlotinib)
Drug: erlotinib (Tarceva)
chemotherapy with erlotinib
Active Comparator: B, pemetrexed
If EGFR wild type found then assigned to chemotherapy (pemetrexed)
Drug: pemetrexed (Alimta)
Chemotherapy with pemetrexed
- The primary analysis will be the overall best response rate, including a 95% confidence interval (Leemis and Trivedi 1996). [ Time Frame: 02/2009 - 04/2010 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903292
|Contact: Wu-Chou Su, PHD||886-6-2353535 ext firstname.lastname@example.org|
|National Cheng-Kung University Hospital||Recruiting|
|Tainan, Taiwan, 704|
|Contact: Hui-Shu Yang, Bachelor +886-6-2353535 ext 4289 email@example.com|
|Principal Investigator:||Wu-Chou Su, PhD||National Cheng-Kung University Hospital|