Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC

Random Open Exploratory Clinical Research of Sequential Gefitinib With Pemetrexed/Platinum Compare With Pemetrexed/Platinum Treatment for Advanced Non-small Cell Lung Cancer Exploratory Clinical Research

The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.

Patients will be randomized to 2 groups

Inclusion Criteria:

1. 18~70 years

2. Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer

3. Presence of at least one index lesion measurable by CT scan or MRI

4. Ecog0-1

5. Expected life time longer than 12 weeks

6. Normal laboratory values:

   • leucocyte ≥ 4×109/L
   • neutrophil ≥ 1.5×109/L
   • platelet ≥ 100×109/L
   • Hemoglobin ≥ 10g/L
   • ALT and
   • AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis)

7. Signed written informed consent

Exclusion Criteria:

• Patients have used drugs according to protocol
• Patients were allergic to pemetrexed or cisplatin
• Patients received radiotherapy or other biological treatment 4 weeks before the trial
• Uncontrolled hydrothorax or hydropericardium
• neuropathy toxicity ≥ CTC 3
• Severe symptomatic heart disease
• Active upper gastrointestinal ulcer or digestive disfunction
• Severe infection or metabolic disfunction
• Patients with other malignant tumor
• Uncontrolled brain metastases
• Patients have accepted other clinical trials
• Female patients during their pregnant and lactation period, or patients without contraception