- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01783834
Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients
February 10, 2016 updated by: Eun Kyung Cho, Gachon University Gil Medical Center
Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients With Advanced Non-small Cell Lung Cancer
To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Incheon, Korea, Republic of
- Gachon University Gil Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: pemetrexed
|
compare PFS rate, safety to both drugs
Other Names:
|
Active Comparator: gefitinib
|
compare progression free survivla rate and safety to both drugs
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall response rate
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival
Time Frame: 5years
|
5years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events
Time Frame: 5years
|
5years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
January 30, 2013
First Submitted That Met QC Criteria
February 4, 2013
First Posted (Estimate)
February 5, 2013
Study Record Updates
Last Update Posted (Estimate)
February 11, 2016
Last Update Submitted That Met QC Criteria
February 10, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Folic Acid Antagonists
- Gefitinib
- Pemetrexed
Other Study ID Numbers
- 2008-GIRBA-1739
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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