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

Study Description

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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)

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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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 ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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Locations

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

AstraZeneca

Investigators

Study Chair:	Jin Soo Lee, M.D.	National Cancer Center, Korea

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Jin Soo Lee, National Cancer Center, Korea
ClinicalTrials.gov Identifier:	NCT00455936 History of Changes
Other Study ID Numbers:	NCCCTS-05-126; D7913L00054 ( Other Grant/Funding Number: AstraZeneca )
First Posted:	April 4, 2007
Last Update Posted:	October 25, 2010
Last Verified:	March 2010

Keywords provided by National Cancer Center, Korea:

Adenocarcinoma; NSCLC; gemcitabine	Cisplatin; Gefitinib; Never smoker

Additional relevant MeSH terms:

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Gemcitabine; Gefitinib; Cisplatin; Antineoplastic Agents; Antimetabolites, Antineoplastic	Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Protein Kinase Inhibitors