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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

Tracking Information
First Submitted Date  ICMJE April 3, 2007
First Posted Date  ICMJE April 4, 2007
Last Update Posted Date October 25, 2010
Study Start Date  ICMJE October 2005
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2010)
overall survival [ Time Frame: every 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2007)
To examine whether gefitinib monotherapy would improve overall survival of never-smokers with adenocarcinoma of lung as compared with standard chemotherapy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2010)
  • To compare Progression-Free survival [ Time Frame: every 9 weeks ]
  • To compare the quality of life [ Time Frame: every 3 weeks ]
  • To compare safety profile [ Time Frame: every 9 weeks ]
  • To collect the tissue samples for the study of predictors of gefitinib (optional) [ Time Frame: screening period ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2007)
  • To compare the objective response rate (CR+PR)
  • To compare disease control rate (SD+PR+CR)
  • To compare time to progression
  • To compare the quality of life
  • To compare safety profile
  • To collect the tissue samples for the study of predictors of gefitinib (optional)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE First-line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker
Official Title  ICMJE 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
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.

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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: Gefitinib
    gefitinib 250mg tablet/ QD daily until Progression
    Other Name: Treamtment Arm
  • 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
Study Arms  ICMJE
  • Experimental: study arm
    Gefitinib 250mg table/QD, daily every 3 weeks
    Intervention: Drug: Gefitinib
  • Active Comparator: control arm
    gemcitabine 1250mg/m2 iv on D1 & D8 every 3 weeks Cisplatin 80mg/m2 iv on D1 every 3 weeks
    Intervention: Procedure: chemotherapy
Publications * Lee Y, Kim SH, Han JY, Kim HT, Yun T, Lee JS. Early neutrophil-to-lymphocyte ratio reduction as a surrogate marker of prognosis in never smokers with advanced lung adenocarcinoma receiving gefitinib or standard chemotherapy as first-line therapy. J Cancer Res Clin Oncol. 2012 Dec;138(12):2009-16. doi: 10.1007/s00432-012-1281-4. Epub 2012 Jul 7.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2008)
Original Enrollment  ICMJE
 (submitted: April 3, 2007)
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00455936
Other Study ID Numbers  ICMJE NCCCTS-05-126
D7913L00054 ( Other Grant/Funding Number: AstraZeneca )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jin Soo Lee, National Cancer Center, Korea
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE National Cancer Center, Korea
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Study Chair: Jin Soo Lee, M.D. National Cancer Center, Korea
PRS Account National Cancer Center, Korea
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP