A Study of Alimta/Cisplatin/Gefitnib for Asian Non-smoking Patients With Non Small Cell Lung Cancer

• Overall survival [ Time Frame: Randomization to date of death from any cause ] [ Designated as safety issue: Yes ]
• Tumour response rate [ Time Frame: Every other cycle for 6 cycles then every 6 weeks ] [ Designated as safety issue: No ]
• Disease control rate [ Time Frame: Every other cycle for 6 cycles then every 6 weeks ] [ Designated as safety issue: No ]
• Time to progressive disease [ Time Frame: Every other cycle for 6 cycles then every 6 weeks from the date of randomization to the first date of measured progressive disease ] [ Designated as safety issue: No ]
• Duration of response [ Time Frame: Every other cycle for 6 cycles then every 6 weeks from the date of initial response to the date of measured progressive disease or death from any cause ] [ Designated as safety issue: No ]
• Time to worsening of health-related quality of life (TWQ) (using the patient-rated Lung Cancer Symptom Scale) [ Time Frame: Every cycle while on-study therapy and at 3 months post last dose ] [ Designated as safety issue: Yes ]

The purpose of this study is to compare two different approaches to treating non small cell lung cancer in East Asian never-smoker patients. Half of the patients will receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti cancer agent (gefitinib) and the other half of the patients will receive only the oral anti cancer agent (gefitinib).

• Drug: Pemetrexed
  500 mg/m2 administered intravenously on day 1 of each 21 day cycle, for 6 cycles
  Other Names:

  • Alimta
  • LY231514
• Drug: Cisplatin
  75 mg/m2 administered intravenously on day 1 of each 21 day cycle, for 6 cycles
• Drug: Gefitinib
  250 mg administered orally once a day, every day of 21 day cycle, for 6 cycles

• Experimental: Pemetrexed + Cisplatin + Gefitinib
  Interventions:

  • Drug: Pemetrexed
  • Drug: Cisplatin
  • Drug: Gefitinib
• Active Comparator: Gefitinib
  Intervention: Drug: Gefitinib

Inclusion Criteria:

• Histological diagnosis of NSCLC with locally advanced or metastatic disease that is of non-squamous histology.

• Patients must be "light ex-smokers" or "never-smokers".

  • "Light ex-smokers" defined as having ceased smoking for greater than or equal to 5 years and not to have exceeded 10 pack-years.
  • "Never-smokers" are defined as having smoked <100 cigarettes or equivalent during his/her lifetime.
• Patients must be of East Asian ethnicity.
• No prior systemic therapy for lung cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

• Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
• Any evidence of clinically active interstitial lung disease. Asymptomatic patients with chronic, stable, radiographic changes are eligible.
• Patients whose Epiderla growth Factor Receptor (EGFR) mutation status is known prior to study entry will be excluded. Patients in which EGFR mutation testing has not been performed, or whose EGFR mutation status is unknown or inconclusive at study entry are eligible.