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

Phase 2

• Conditions: Nonsmall Cell Lung Cancer
• Interventions: Drug: salvage iressa

• Registration Number: NCT01312337
• Lead Sponsor: Samsung Medical Center

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 available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-02-21
• Status Verified: 2011-03
• Study First Submitted QC: 2011-03-08
• Last Update Submitted: 2011-03-08
• Study First Posted: 2011-03-10
• Last Update Posted: 2011-03-10
• Primary Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iressa for EGFR wild group	salvage iressa	salvage Iressa therapy for patients with EGFR mutation negative NSCLC patients

Primary Outcome Measures

Name	Time	Method
To determine disease control rate at 8 weeks will be 35% or higher in the the study group	6 months after the enrollment of the last patients

Secondary Outcome Measures

Name	Time	Method
The number of patients who live longer than 6 months after enrollment	6 months after the enrollment of the last patients

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of