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

A Phase II Trial of Gefitinib Monotherapy in Pretreated Patients With Advanced Non-small Cell Lung Cancer Not Harboring Active EGFR Mutations

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

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