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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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01066195
First received: February 8, 2010
Last updated: February 9, 2010
Last verified: February 2010

February 8, 2010
February 9, 2010
May 2008
October 2010   (final data collection date for primary outcome measure)
progression-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01066195 on ClinicalTrials.gov Archive Site
  • overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • objective response rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pemetrexed (ALIMTA) and Gefitinib (IRESSA®) in Never-Smoker and Adenocarcinoma Patients With Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • Drug: iressa
    iressa 250mg per day every day
  • Drug: alimta
    alimta 500mg/m2 every 3 weeks
  • Experimental: gefitinib
    Intervention: Drug: iressa
  • Active Comparator: pemetrexed
    Intervention: Drug: alimta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
129
Not Provided
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01066195
2008-04-030
Not Provided
Myungju Ahn Ph.D., M.D., Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Myungju Ahn, Ph.D., M.D. Samsung Medical Center
Samsung Medical Center
February 2010

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