Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2013 by Gachon University Gil Medical Center.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Eun Kyung Cho, Gachon University Gil Medical Center Identifier:
First received: January 30, 2013
Last updated: August 19, 2013
Last verified: August 2013
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 5years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 5years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 116
Study Start Date: February 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pemetrexed
Drug: Pemetrexed
Active Comparator: gefitinib
Drug: Gefitinib


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01783834

Contact: Hee Kyung Ahn, professor +82-32-460-2625

Korea, Republic of
Gachon university Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: HeeKyung Ahn, professor    +82-32-460-2625   
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

No publications provided

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: August 19, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on February 04, 2016