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A Randomized Phase III Study of Gefitinib (IRESSATM) Versus Standard Chemotherapy (Gemcitabine Plus Cisplatin) as First-line Treatment for in Never Smokers Advance or Metastatic Adenocarcinoma of Lung

Phase 3
18 Years
75 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Randomized Phase III Study of Gefitinib (IRESSATM) Versus Standard Chemotherapy (Gemcitabine Plus Cisplatin) as First-line Treatment for in Never Smokers Advance or Metastatic Adenocarcinoma of Lung

Gefitinib (Iressa TM) Arm - Gefitinib administration 250mg tablet once daily every 3 weeks

standard chemotherapy arm - gemcitabine (1,250mg/m2 for 30 minutes on day 1 and 8 of a 3
week cycle) plus cisplatin (80mg/m2 on day 1 of a 3 week cycle)

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of adenocarcinoma of lung with or
without BAC features; however, adenocarcinoma combined with other histology, such as
small cell carcinoma or squamous carcinoma, is not allowed.

2. Stage IIIB with malignant pleural effusion/pleural seeding or stage IV patients

3. Age 18-75

4. Never-smoking defined as not more than 100 cigarettes during the lifetime

5. ECOG performance status of 0-2

6. No prior invasive malignancies 5 years prior to study entry except adequately treated
cutaneous basal cell carcinoma or uterine cervix in situ cancer

7. Serum creatinine ≤ 1.5 mg/dL, serum bilirubin ≤ 1.2 mg/dL (1 x UNL) and SGOT/SGPT ≤
100 IU/L (2.5 x UNL)

8. Serum Hgb ≥ 10 gm/dl, platelet count ≥ 100,000/ul, total WBC count >= 4,000/uL,
absolute neutrophil count ≥ 1,500/ul

9. Patients must sign an informed consent indicating that they are aware of the
investigational nature of the study in keeping with the policy of the hospital. The
only approved consent form is attached to this protocol

10. The presence of CNS metastases is not considered as an exclusion criterion, provided
that there is good control of the symptoms with corticosteroids

Exclusion Criteria:

1. Pregnancy or breast-feeding (women of child-bearing potential). Women of childbearing
potential must practice acceptable methods of birth control to prevent pregnancy.

2. Major surgery other than biopsy within the past two week.

3. Known severe hypersensitivity to Gefitinib or any of the excipients of this product

4. Any evidence of clinically active interstitial lung disease (patients with chronic,
stable, radiographic changes who are asymptomatic need not be excluded)

5. As judged by the investigator, any evidence of severe or uncontrolled systemic
disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal

6. Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the subject to participate in the study

7. Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's

8. Treatment with a non-approved or investigational drug within 30 days before Day 1 of
study treatment.

Type of Study:


Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

every 12 weeks

Safety Issue:


Principal Investigator

Jin Soo Lee, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Center, Korea


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

October 2005

Completion Date:

March 2010

Related Keywords:

  • Lung Cancer
  • Adenocarcinoma
  • gemcitabine
  • Cisplatin
  • Gefitinib
  • Never smoker
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Lung Neoplasms