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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Nonsmall Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine disease control rate at 8 weeks will be 35% or higher in the the study group

Outcome Time Frame:

6 months after the enrollment of the last patients

Safety Issue:

No

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

2010-07-252

NCT ID:

NCT01312337

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Nonsmall Cell Lung Cancer
  • gefitinib
  • EGFR mutation negative
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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