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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01312337

Enrollment

Registered

2011-03-10

Start date

2010-09-30

Completion date

Unknown

Last updated

2011-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonsmall Cell Lung Cancer

Keywords

gefitinib, EGFR mutation negative, NSCLC

Brief summary

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

Interventions

DRUGsalvage iressa

Iressa 250mg per day until progression

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The number of patients who live longer than 6 months after enrollment	6 months after the enrollment of the last patients

Countries

South Korea

Contacts

Primary ContactMyung-Ju Ahn, Pf

silkahn@skku.edu82-2-3410-3459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026