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

Nonsmall Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01312337
• Other study ID #: 2010-07-252
• Status: Recruiting
• Phase: Phase 2
• First received: February 21, 2011
• Last updated: March 8, 2011
• Start date: September 2010

Study information

• Verified date: March 2011
• Source: Samsung Medical Center
• Contact: Myung-Ju Ahn, Pf
• Phone: 82-2-3410-3459
• Email: silkahn[@]skku.edu
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Nonsmall Cell Lung Cancer

Intervention

Drug:
• salvage iressa
Iressa 250mg per day until progression

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The number of patients who live longer than 6 months after enrollment		6 months after the enrollment of the last patients	No