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

NCT01312337 | Unknown Phase 2

• 1 other identifier: 2010-07-252
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Nonsmall Cell Lung Cancer

Keywords

gefitinib; EGFR mutation negative; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The number of patients who live longer than 6 months after enrollment

  6 months after the enrollment of the last patients

Study Arms (1)

Iressa for EGFR wild group

EXPERIMENTAL

salvage Iressa therapy for patients with EGFR mutation negative NSCLC patients

Drug: salvage iressa

Interventions

salvage iressa DRUG

Iressa 250mg per day until progression

Iressa for EGFR wild group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (2)

Samsung Medical Center

Seoul, 135-710, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Myung-Ju Ahn, Pf

CONTACT

82-2-3410-3459; silkahn@skku.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 21, 2011
• First Posted: March 10, 2011
• Study Start: September 1, 2010
• Primary Completion: August 1, 2012
• Last Updated: March 10, 2011

Record last verified: 2011-03

Locations

KR (2)