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Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients

Primary Purpose

Previous Treated Metastatic Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Gefitinib

Pemetrexed

About this trial

This is an interventional treatment trial for Previous Treated Metastatic Non-small Cell Lung Cancer focused on measuring Pemetrexed, Gefitinib, iressa, alimta

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gachon university Gil Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

pemetrexed

gefitinib

Arm Description

pemetrexed

gefitinib

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Progression free survival

Full Information

NCT ID

NCT01783834

First Posted

January 30, 2013

Last Updated

February 10, 2016

Sponsor

Gachon University Gil Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01783834

Brief Title

Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients

Official Title

Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients With Advanced Non-small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gachon University Gil Medical Center

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Previous Treated Metastatic Non-small Cell Lung Cancer

Keywords

Pemetrexed, Gefitinib, iressa, alimta

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pemetrexed

Arm Type

Active Comparator

Arm Description

pemetrexed

Arm Title

gefitinib

Arm Type

Active Comparator

Arm Description

gefitinib

Intervention Type

Drug

Intervention Name(s)

Gefitinib

Other Intervention Name(s)

irressa

Intervention Description

compare progression free survivla rate and safety to both drugs

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

alimta

Intervention Description

compare PFS rate, safety to both drugs

Primary Outcome Measure Information:

Title

Overall response rate

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Progression free survival

Time Frame

5years

Other Pre-specified Outcome Measures:

Title

Number of participants with adverse events

Time Frame

5years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Gachon university Gil Medical Center

City

Incheon

Country

Korea, Republic of

12. IPD Sharing Statement

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Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients

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