Back to resultsIressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)
Primary Purpose
Nonsmall Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
salvage iressa
Sponsored by
About this trial
This is an interventional treatment trial for Nonsmall Cell Lung Cancer focused on measuring gefitinib, EGFR mutation negative, NSCLC
Eligibility 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
Sites / Locations
- Samsung Medical Center
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Iressa for EGFR wild group
Arm Description
salvage Iressa therapy for patients with EGFR mutation negative NSCLC patients
Outcomes
Primary Outcome Measures
To determine disease control rate at 8 weeks will be 35% or higher in the the study group
Secondary Outcome Measures
The number of patients who live longer than 6 months after enrollment
Full Information
NCT ID
NCT01312337
First Posted
February 21, 2011
Last Updated
March 8, 2011
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01312337
Brief Title
Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)
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 Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsmall Cell Lung Cancer
Keywords
gefitinib, EGFR mutation negative, NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iressa for EGFR wild group
Arm Type
Experimental
Arm Description
salvage Iressa therapy for patients with EGFR mutation negative NSCLC patients
Intervention Type
Drug
Intervention Name(s)
salvage iressa
Intervention Description
Iressa 250mg per day until progression
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The number of patients who live longer than 6 months after enrollment
Time Frame
6 months after the enrollment of the last patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myung-Ju Ahn, Pf
Phone
82-2-3410-3459
Email
silkahn@skku.edu
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Ju Ahn, Pf
Phone
822-3410-3459
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Ju ahn, Pf
Phone
82-2-3410-3459
Email
silkahn@skku.edu
12. IPD Sharing Statement
Learn more about this trial
Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)
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