A Study Comparing Two Different Chemotherapy Types in Chinese Patients With Advanced Non Small Cell Lung Cancer

• Progression free survival [ Time Frame: Randomization to the first date of progressive disease or death from any cause ] [ Designated as safety issue: No ]
• Time to progressive disease [ Time Frame: Randomization to the first date of measured progressive disease ] [ Designated as safety issue: No ]
• Duration of response [ Time Frame: Date of first response to the date of progressive disease or death from any cause ] [ Designated as safety issue: No ]
• Time to treatment failure [ Time Frame: Randomization until the date of discontinuation of study treatment due to adverse events, progressive disease (PD), or death from any cause ] [ Designated as safety issue: Yes ]
• Tumour response rate [ Time Frame: Assessed at baseline and every 2 cycles, for 6 cycles during therapy ] [ Designated as safety issue: No ]
• Risk/benefit ratio (the ratio of the percentage of patients experiencing a toxicity (CTC Grade 3 or higher) to the Kaplan-Meier estimated percentage of patients surviving one year [ Time Frame: Randomization to date of death from any cause (includes post-treatment follow-up of up to 24 months post-Last Patient Entered Treatment) ] [ Designated as safety issue: No ]

The purpose of this study is to compare the efficacy and safety of two different chemotherapy types in the first line treatment of advanced Non-Small Cell Lung Cancer (NSCLC).

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

  • Alimta
  • LY231514
• Drug: Gemcitabine
  1250 mg/m2 administered intravenously on day 1 and day 8 of each 21 day cycle, for 6 cycles
  Other Names:

  • Gemzar
  • LY188011
• Drug: Cisplatin
  75 mg/m2 administered intravenously on day 1 of each 21 day cycle, for 6 cycles

• Experimental: Pemetrexed plus Cisplatin
  Interventions:

  • Drug: Pemetrexed
  • Drug: Cisplatin
• Active Comparator: Gemcitabine plus Cisplatin
  Interventions:

  • Drug: Gemcitabine
  • Drug: Cisplatin

Inclusion Criteria:

• Present with histologically proven or cytological diagnosis of non-squamous NSCLC Stage IIIB or IV.
• Patients must agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug.
• Female patients must not be pregnant.
• No prior systemic chemotherapy for lung cancer.
• At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors.
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
• Adequate organ function.
• Prior radiation therapy allowed to <25% of the bone marrow.
• Signed informed consent document on file.
• Estimated life expectancy of greater than or equal to 12 weeks.
• Patient compliance and geographic proximity that allow adequate follow up.

Exclusion Criteria:

• Peripheral neuropathy of great than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
• Inability to comply with protocol or study procedures.
• A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
• A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
• Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
• Documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has not taken corticosteroids for at least 4 weeks before enrollment.
• Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
• Significant weight loss (that is, greater than or equal to 10%) over the previous 6 weeks before study entry.
• Concurrent administration of any other anti-tumor therapy.
• Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents, such as piroxicam).
• Inability or unwillingness to take folic acid or vitamin B12 supplementation.
• Inability to take corticosteroids.
• Pregnant or breast-feeding.
• Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.