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Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients

This study has been completed.
Information provided by (Responsible Party):
Eun Kyung Cho, Gachon University Gil Medical Center Identifier:
First received: January 30, 2013
Last updated: February 10, 2016
Last verified: February 2016
To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer

Condition Intervention Phase
Previous Treated Metastatic Non-small Cell Lung Cancer Drug: Gefitinib Drug: Pemetrexed Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Eun Kyung Cho, Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 5years ]

Other Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 5years ]

Enrollment: 95
Study Start Date: February 2008
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pemetrexed
Drug: Pemetrexed
compare PFS rate, safety to both drugs
Other Name: alimta
Active Comparator: gefitinib
Drug: Gefitinib
compare progression free survivla rate and safety to both drugs
Other Name: irressa


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01783834

Korea, Republic of
Gachon university Gil Medical Center
Incheon, Korea, Republic of
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

Responsible Party: Eun Kyung Cho, professor, Gachon University Gil Medical Center Identifier: NCT01783834     History of Changes
Other Study ID Numbers: 2008-GIRBA-1739
Study First Received: January 30, 2013
Last Updated: February 10, 2016

Keywords provided by Eun Kyung Cho, Gachon University Gil Medical Center:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors processed this record on August 18, 2017