Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)
Conditions
Nonsmall Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
gefitinib, EGFR mutation negative, NSCLC
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: salvage iressa
Type: Drug
Overall Status
Recruiting
Summary
The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Samsung Medical Center
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Myung-Ju Ahn, Pf - 822-3410-3459
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Myung-Ju ahn, Pf - 82-2-3410-3459 - silkahn@skku.edu
Start Date
September 2010
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page