Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)
Nonsmall Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
gefitinib, EGFR mutation negative, NSCLC
Study Type
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: salvage iressa
Type: Drug
Overall Status
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
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 -
Start Date
September 2010
Samsung Medical Center
Samsung Medical Center
Record processing date processed this data on July 28, 2015 page