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

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. Identifier: NCT01312337
Recruitment Status : Unknown
Verified March 2011 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : March 10, 2011
Last Update Posted : March 10, 2011
Information provided by:
Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
Nonsmall Cell Lung Cancer Drug: salvage iressa Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: N/A
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
Study Start Date : September 2010
Estimated Primary Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

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

Primary Outcome Measures :
  1. 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 :
  1. The number of patients who live longer than 6 months after enrollment [ Time Frame: 6 months after the enrollment of the last patients ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01312337

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Contact: Myung-Ju Ahn, Pf 82-2-3410-3459

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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   
Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: Myung-Ju Ahn / Professor, Samsung Medical Center Identifier: NCT01312337    
Other Study ID Numbers: 2010-07-252
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: March 2011
Keywords provided by Samsung Medical Center:
EGFR mutation negative
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action