Status:
COMPLETED
Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
AstraZeneca
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a double blind, multicentre, randomized, placebo-controlled study. The eligible patients will be randomized to receive gefitinib or placebo at 1:1 ratio. This study will recruit 296 male or fe...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed locally advanced or metastatic (stage=IIIB/IV) non-small cell lung cancer (NSCLC) before the front line chemotherapy. Note: sputum cytology alone is not acceptable
- Patients have completed 4 cycles of first line platinum contained doublet chemotherapy without progression or intolerable toxicity.
- Patients with PR or SD on study entry need to have one or more measurable lesions according to RECIST criteria.
- The study treatment should be started at least 3 weeks (21 days) but no more than 6 weeks (42 days) since last dose of chemotherapy, and within 4 weeks (28 days) since last tumour assessment.
Exclusion
- Prior exposure to monoclonal antibodies or small molecule inhibitors against EGFR receptors. (e.g. gefitinib, erlotinib, C225)
- Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they are clinically stable and have been discontinued from steroid therapy for at least 4 weeks prior to first dose of study medication.
- Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- Known biomarker status of one or more of the following: Tumour EGFR gene copy number, tumour EGFR gene mutation status, tumour EGFR protein expression.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT00770588
Start Date
September 1 2008
End Date
February 1 2011
Last Update
February 8 2016
Active Locations (14)
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1
Research Site
Beijing, Beijing Municipality, China
2
Research Site
Fuzhou, Fujian, China
3
Research Site
Guangzhou, Guangdong, China
4
Research Site
Nanning, Guangxi, China