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First-line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00455936
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : October 25, 2010
Information provided by:
National Cancer Center, Korea

Brief Summary:

The investigators will conduct the randomized trial to determine the role of Gefitinib monotherapy as first-line setting in adenocarcinoma patients with no history of smoking, as compared with the standard combination chemotherapy.

This is a randomized, open label, parallel group, phase III study in never-smokers with advanced or metastatic adenocarcinoma of lung.

After stratification by gender, performance status, and disease stage, patients will be randomized to one of the two treatment arms to receive either gefitinib or standard chemotherapy until clinical or objective disease progression, unacceptable toxicity or patient's refusal, whichever is sooner. The chemotherapy will be administered for no more than nine cycles.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Gefitinib Procedure: chemotherapy Phase 3

Detailed Description:

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: study arm
Gefitinib 250mg table/QD, daily every 3 weeks
Drug: Gefitinib
gefitinib 250mg tablet/ QD daily until Progression
Other Name: Treamtment Arm

Active Comparator: control arm
gemcitabine 1250mg/m2 iv on D1 & D8 every 3 weeks Cisplatin 80mg/m2 iv on D1 every 3 weeks
Procedure: chemotherapy
gemcitabine(1250mg/m2 iv on D1 & 8) plus Cisplatin (80mg/m2 iv on D1) every 3 weeks, maximum 9 cycles
Other Name: standard chemotherapy arm

Primary Outcome Measures :
  1. overall survival [ Time Frame: every 12 weeks ]

Secondary Outcome Measures :
  1. To compare Progression-Free survival [ Time Frame: every 9 weeks ]
  2. To compare the quality of life [ Time Frame: every 3 weeks ]
  3. To compare safety profile [ Time Frame: every 9 weeks ]
  4. To collect the tissue samples for the study of predictors of gefitinib (optional) [ Time Frame: screening period ]
  5. To compare the objective response rate (CR+PR) [ Time Frame: from the date of randomization to the date of death from any cause the result of each should be recorded separately ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00455936

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Korea, Republic of
National Cancer Center, Korea
Goyang-si, Gyenggi-do, Korea, Republic of, 411-769
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
National Cancer Center, Korea
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Study Chair: Jin Soo Lee, M.D. National Cancer Center, Korea
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jin Soo Lee, National Cancer Center, Korea Identifier: NCT00455936    
Other Study ID Numbers: NCCCTS-05-126
D7913L00054 ( Other Grant/Funding Number: AstraZeneca )
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: March 2010
Keywords provided by National Cancer Center, Korea:
Never smoker
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action