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)
Condition: Non-small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Gefitinib; Placebo
Intervention description: Dose form: 250 mg/tablet; Route: oral; Frequency: 1 tablet per day; Duration: until to objective PD; To match Gefitinib
Intervention MeSH terms: Gefitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 296.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-small cell lung cancer (NSCLC); Gefitinib

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 female, histologically or cytologically diagnosed locally advanced or
      metastatic NSCLC patients with a World Health Organization (WHO) Performance Status (PS) 0-2.
      Patients must have completed 4 cycles of platinum based first line doublet chemotherapy
      without experiencing disease progression or unacceptable toxicity. The chemotherapy shall be
      given every 3 weeks, which includes cisplatin or carboplatin, combined with any one of the
      following: gemcitabine, paclitaxel, docetaxel, vinorelbine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.