Gachon university Gil Medical Center
Incheon, South Korea
Completed
NCT Number: NCT01783834
Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients
To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Cells pathologically diagnosed as histological or radical surgery or radiation therapy is not possible stage IIIB and stage IV non-small-cell lung cancer patients
- second line
- ECOG 0～2
- Patients with normal liver function and renal function
Exclusion criteria
- Patients with severe acute infection requiring antibiotic therapy
- Patients who have received treatment in other areas of cancer within 5 years
- During pregnancy and lactation patients
Treatment and study plan
Gefitinib
Drugcompare progression free survivla rate and safety to both drugs
Other names: irressa
Pemetrexed
Drugcompare PFS rate, safety to both drugs
Other names: alimta
Primary outcomes
-
Overall response rate
Time frame: 5 years
Secondary outcomes
-
Progression free survival
Time frame: 5years
Other outcomes
-
Number of participants with adverse events
Time frame: 5years
Sponsors and collaborators
Lead sponsor
Gachon University Gil Medical Center
Other
Registry information
Official study title
Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients With Advanced Non-small Cell Lung Cancer
Important dates
- Study start
- 2008
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Feb 5, 2013
- Registry last updated
- Feb 11, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.