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Randomized Phase II Trail Comparing Gefitinib Plus Simvastatin and Gefitinib Alone in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Randomized Phase II Trail Comparing Gefitinib Plus Simvastatin and Gefitinib Alone in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)


1. Sex (female vs. male)

2. ECOG PS (0/1 vs. 2/3)

3. Number of prior regimen (one vs. two).

Gefitinib (250 mg per day) + Simvastatin (40 mg per day) PO or Gefitinib (250 mg per day)

until progression or unacceptable toxicity

Inclusion Criteria:

1. Histologic or cytologic diagnosis of NSCLC

2. Stage IV or selected stage IIIB (with positive pleural effusion or multiple
ipsilateral lung nodules) according to the American Joint Committee on Cancer (AJCC).

3. Previously treated with at least one platinum-based chemotherapy.

4. Before study entry, a minimum of 21 days must have elapsed since any prior

5. Prior radiation therapy is allowed as long as the irradiated area is not the only
source of measurable disease.

6. No other forms of cancer therapy, such as radiation, immunotherapy for at least 2
weeks before the enrollment in study.

7. Performance status of 0-3 on the ECOG criteria.

8. At least one unidimensional measurable lesion meeting Response Evaluation Criteria in
Solid Tumors (RECIST. 2000).- Estimated life expectancy of at least 8 weeks.

9. Patient compliance that allow adequate follow-up.

10. Adequate hematologic (ANC count ≥ 1,000/uL, platelet count ≥ 150,000/mm3), hepatic
(bilirubin level≤1.5 mg/dL, AST/ALT ≤ 80 IU/L), and renal (creatinine concentration ≤
1.5 mg/dL) function.

11. Informed consent from patient or patient's relative.

12. Males or females at least 18 years of age.

13. If female: childbearing potential either terminated by surgery, radiation, or
menopause, or attenuated by use of an approved contraceptive method (intrauterine
device [IUD], birth control pills, or barrier device) during and for 3 months after
trial. If male, use of an approved contraceptive method during the study and 3
months afterwards. Females with childbearing potential must have a urine negative hCG
test within 7 days prior to the study enrollment.

14. No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital,
phenytoin, ketoconazole.

15. Patients with brain metastasis are allowed unless there were clinically significant
neurological symptoms or signs

Exclusion Criteria:

1. Presence of small-cell lung cancer alone or with NSCLC- Unresolved chronic toxic
effects from previous anticancer therapy

2. Known severe hypersensitivity to gefitinib or any of the tablet excipients

3. Inability to swallow tablets

4. Other coexisting malignant disease (apart from basal-cell carcinoma)

5. More than three previous chemotherapy regimens for NSCLC

6. Previous treatment with an experimental agent of which the main mechanism of action
is inhibition of epidermal growth factor receptor or its associated tyrosine kinase

7. Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's
wort; severe or uncontrolled systemic disease; clinically active interstitial lung
disease (except uncomplicated lymphangitic carcinomatosis) pregnancy; and

8. MI within preceding 6 months or symptomatic heart disease, including unstable angina,
congestive heart failure or uncontrolled arrhythmia

9. Serious concomitant infection including post obstructive pneumonia

10. Major surgery other than biopsy within the past two weeks.

11. Pregnant or breast-feeding.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response rate

Outcome Description:

from C1D1 until confirmed disease progression

Outcome Time Frame:

every 8 weeks

Safety Issue:


Principal Investigator

Ji-Youn Han, M.D.,Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

May 2006

Completion Date:

March 2011

Related Keywords:

  • Lung Cancer
  • Gefitinib
  • Simvastatin
  • Advanced NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms