NCT01783834

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

6.3 years

First QC Date

January 30, 2013

Last Update Submit

February 10, 2016

Conditions

Previous Treated Metastatic Non-small Cell Lung Cancer

Keywords

PemetrexedGefitinibiressaalimta

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    5 years

Secondary Outcomes (1)

  • Progression free survival

    5years

Other Outcomes (1)

  • Number of participants with adverse events

    5years

Study Arms (2)

pemetrexed

ACTIVE COMPARATOR

pemetrexed

Drug: Pemetrexed

gefitinib

ACTIVE COMPARATOR

gefitinib

Drug: Gefitinib

Interventions

GefitinibDRUG

compare progression free survivla rate and safety to both drugs

Also known as: irressa
gefitinib
PemetrexedDRUG

compare PFS rate, safety to both drugs

Also known as: alimta
pemetrexed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon university Gil Medical Center

Incheon, South Korea

Location

MeSH Terms

Interventions

GefitinibPemetrexed

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGuanineHypoxanthinesPurinonesPurinesGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 5, 2013

Study Start

February 1, 2008

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 11, 2016

Record last verified: 2016-02

Locations

KR(1)