Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)

March 8, 2011 updated by: Samsung Medical Center

A Phase II Trial of Gefitinib Monotherapy in Pretreated Patients With Advanced Non-small Cell Lung Cancer Not Harboring Active EGFR Mutations

The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

92

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, Korea, Republic of, 135-710
        • Not yet recruiting
        • Samsung Medical Center
        • Contact:
          • Myung-Ju Ahn, Pf
          • Phone Number: 822-3410-3459

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically proven NSCLC
  • Ineligibile for curative treatment (namely, stage IIIb or IV)
  • History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21)
  • At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1)
  • 18 years old or older
  • Performance status ECOG 0-2

  • Adequate organ function as evidenced by the following:

    • Absolute neutrophil count > 1.0 x 109/L
    • Platelets > 75 x 109/L
    • Total bilirubin ≤ 1.5 UNL
    • AST and/or ALT < 5 UNL
    • Creatinine clearance ≥ 45mL/min

Exclusion Criteria:

  • Previous EGFR TKI therapy history
  • Systemic anticancer therapy within the previous 3 weeks
  • Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer
  • Other concurrent illness that would preclude study participation (severe heart disease)
  • Other concurrent physical condition (e.g., infectious disease) that would preclude study participation
  • Pregnant or nursing

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iressa for EGFR wild group
salvage Iressa therapy for patients with EGFR mutation negative NSCLC patients
Drug: salvage iressa
Iressa 250mg per day until progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine disease control rate at 8 weeks will be 35% or higher in the the study group
Time Frame: 6 months after the enrollment of the last patients
6 months after the enrollment of the last patients

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of patients who live longer than 6 months after enrollment
Time Frame: 6 months after the enrollment of the last patients
6 months after the enrollment of the last patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung 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

September 1, 2010

Primary Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

February 21, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 10, 2011

Study Record Updates

Last Update Posted (Estimate)

March 10, 2011

Last Update Submitted That Met QC Criteria

March 8, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-07-252

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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