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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Samsung Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01312337
First Posted: March 10, 2011
Last Update Posted: March 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Samsung Medical Center
  Purpose
The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.

Condition Intervention Phase
Nonsmall Cell Lung Cancer Drug: salvage iressa Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Gefitinib Monotherapy in Pretreated Patients With Advanced Non-small Cell Lung Cancer Not Harboring Active EGFR Mutations

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • The number of patients who live longer than 6 months after enrollment [ Time Frame: 6 months after the enrollment of the last patients ]

Estimated Enrollment: 92
Study Start Date: September 2010
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312337


Contacts
Contact: Myung-Ju Ahn, Pf 82-2-3410-3459 silkahn@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of, 135-710
Contact: Myung-Ju Ahn, Pf    822-3410-3459      
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Myung-Ju ahn, Pf    82-2-3410-3459    silkahn@skku.edu   
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: Myung-Ju Ahn / Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01312337     History of Changes
Other Study ID Numbers: 2010-07-252
First Submitted: February 21, 2011
First Posted: March 10, 2011
Last Update Posted: March 10, 2011
Last Verified: March 2011

Keywords provided by Samsung Medical Center:
gefitinib
EGFR mutation negative
NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action