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Pemetrexed (ALIMTA) and Gefitinib (IRESSA®) in Never-Smoker and Adenocarcinoma Patients With Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

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: NCT01066195
Recruitment Status : Unknown
Verified February 2010 by Samsung Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : February 10, 2010
Last Update Posted : February 10, 2010
Information provided by:
Samsung Medical Center

Brief Summary:

Pemetrexed was known to be effective to pulmonary adenocarcinoma and gefitinib was known to be more effective to non-small cell lung cancer (NSCLC) patients with clinical characteristics such as adenocarcinoma, never smoker and female.

The investigators try to evaluate which drug (pemetrexed vs gefitinib) is more efficious to NSCLC patients with clinical characteristics such as adenocarcinoma and never smoking history as second- or further-line therapy.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: iressa Drug: alimta Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-center, Randomized Trial of Pemetrexed and Gefitinib in Never-smoker and Adenocarcinoma Patients With Non-small Cell Lung Cancer Previously Treated With Platinum-based Chemotherapy
Study Start Date : May 2008
Estimated Primary Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: gefitinib Drug: iressa
iressa 250mg per day every day
Active Comparator: pemetrexed Drug: alimta
alimta 500mg/m2 every 3 weeks

Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 36 months ]
  2. objective response rate [ Time Frame: 36 months ]
  3. toxicity [ Time Frame: 36 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Histologically confirmed pulmonary adenocarcinoma including bronchioloalveolar, but except adenosquamous cell carcinoma
  2. Stage IIIB (malignant pleural effusion and/or pleural seeding), stage IV and relapsed non-small cell lung cancer
  3. Failed with 1st line platinum-based chemotherapy or relapsed within 12 months after adjuvant platinum-based chemotherapy)
  4. Never smoker (less than 100 cigarette for the life time)
  5. 18 year or older
  6. ECOG 0-2
  7. No history of biologic or immunotherapy
  8. Tolerable renal function ( creatine clearance rate is 60ml/min or more)
  9. Tolerable hepatic function (Serum bilirubin ≤ 1.25 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤5 x UNL)

Exclusion Criteria:

  1. symptomatic brain metastasis
  2. previously treated with EGFR tyrosine kinase inhibitor
  3. previously treated with antifolate agents
  4. poor oral absorption
  5. patients with active infection
  6. uncontrolled diabetes mellitus
  7. significant cardiovascular disease (uncontrolled hypertension, history of myocardial infarction or unstable angina within 6 months, congestive heart failure)
  8. pregnant or nursing patients
  9. history of malignant disease within 3 years before the enrollment except for cured non-melanomatous skin cancer, cervical carcinoma in situ, or thyroid carcinoma

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): NCT01066195

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Myungju Ahn, Ph.D., M.D. Samsung Medical Center

Responsible Party: Myungju Ahn Ph.D., M.D., Samsung Medical Center Identifier: NCT01066195     History of Changes
Other Study ID Numbers: 2008-04-030
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: February 10, 2010
Last Verified: February 2010

Keywords provided by Samsung Medical Center:
Non-Small Cell Lung Cancer
Never-Smoker and Adenocarcinoma patients
Pemetrexed (ALIMTA)
Gefitinib (IRESSA®)

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors