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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by:
Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE February 21, 2011
First Posted Date  ICMJE March 10, 2011
Last Update Posted Date March 10, 2011
Study Start Date  ICMJE September 2010
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2011)
The number of patients who live longer than 6 months after enrollment [ Time Frame: 6 months after the enrollment of the last patients ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)
Official Title  ICMJE A Phase II Trial of Gefitinib Monotherapy in Pretreated Patients With Advanced Non-small Cell Lung Cancer Not Harboring Active EGFR Mutations
Brief Summary The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nonsmall Cell Lung Cancer
Intervention  ICMJE Drug: salvage iressa
Iressa 250mg per day until progression
Study Arms  ICMJE Experimental: Iressa for EGFR wild group
salvage Iressa therapy for patients with EGFR mutation negative NSCLC patients
Intervention: Drug: salvage iressa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 8, 2011)
92
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01312337
Other Study ID Numbers  ICMJE 2010-07-252
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Myung-Ju Ahn / Professor, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Medical Center
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP