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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01783834
Other study ID # 2008-GIRBA-1739
Secondary ID
Status Completed
Phase Phase 2
First received January 30, 2013
Last updated February 10, 2016
Start date February 2008
Est. completion date June 2014

Study information

Verified date February 2016
Source Gachon University Gil Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Gefitinib
compare progression free survivla rate and safety to both drugs
Pemetrexed
compare PFS rate, safety to both drugs

Locations

Country Name City State
Korea, Republic of Gachon university Gil Medical Center Incheon

Sponsors (1)

Lead Sponsor Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of participants with adverse events 5years Yes
Primary Overall response rate 5 years No
Secondary Progression free survival 5years No