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

Conditions

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

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
Drug: Pemetrexed
compare PFS rate, safety to both drugs
Other Names:
  • alimta
Active Comparator: gefitinib
Drug: Gefitinib
compare progression free survivla rate and safety to both drugs
Other Names:
  • irressa

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.

Sponsor

Gachon University Gil Medical Center

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

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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