Pemetrexed (ALIMTA) and Gefitinib (IRESSA®) in Never-Smoker and Adenocarcinoma Patients With Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01066195|
Recruitment Status : Unknown
Verified February 2010 by Samsung Medical Center.
Recruitment status was: Enrolling by invitation
First Posted : February 10, 2010
Last Update Posted : February 10, 2010
Pemetrexed was known to be effective to pulmonary adenocarcinoma and gefitinib was known to be more effective to non-small cell lung cancer (NSCLC) patients with clinical characteristics such as adenocarcinoma, never smoker and female.
The investigators try to evaluate which drug (pemetrexed vs gefitinib) is more efficious to NSCLC patients with clinical characteristics such as adenocarcinoma and never smoking history as second- or further-line therapy.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: iressa Drug: alimta||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||129 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Multi-center, Randomized Trial of Pemetrexed and Gefitinib in Never-smoker and Adenocarcinoma Patients With Non-small Cell Lung Cancer Previously Treated With Platinum-based Chemotherapy|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||October 2010|
iressa 250mg per day every day
|Active Comparator: pemetrexed||
alimta 500mg/m2 every 3 weeks
- progression-free survival [ Time Frame: 36 months ]
- overall survival [ Time Frame: 36 months ]
- objective response rate [ Time Frame: 36 months ]
- toxicity [ Time Frame: 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066195
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Myungju Ahn, Ph.D., M.D.||Samsung Medical Center|