Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients
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ClinicalTrials.gov Identifier: NCT01783834 |
Recruitment Status :
Completed
First Posted : February 5, 2013
Last Update Posted : February 11, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Previous Treated Metastatic Non-small Cell Lung Cancer | Drug: Gefitinib Drug: Pemetrexed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 95 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients With Advanced Non-small Cell Lung Cancer |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: pemetrexed
pemetrexed
|
Drug: Pemetrexed
compare PFS rate, safety to both drugs
Other Name: alimta |
Active Comparator: gefitinib
gefitinib
|
Drug: Gefitinib
compare progression free survivla rate and safety to both drugs
Other Name: irressa |
- Overall response rate [ Time Frame: 5 years ]
- Progression free survival [ Time Frame: 5years ]
- Number of participants with adverse events [ Time Frame: 5years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01783834
Korea, Republic of | |
Gachon university Gil Medical Center | |
Incheon, Korea, Republic of |
Responsible Party: | Eun Kyung Cho, professor, Gachon University Gil Medical Center |
ClinicalTrials.gov Identifier: | NCT01783834 |
Other Study ID Numbers: |
2008-GIRBA-1739 |
First Posted: | February 5, 2013 Key Record Dates |
Last Update Posted: | February 11, 2016 |
Last Verified: | February 2016 |
Pemetrexed Gefitinib iressa alimta |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Pemetrexed Gefitinib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors |