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

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

Detailed Description
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Patients will be randomized to 2 groups

Official Title
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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

Conditions
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NSCLC

Intervention / Treatment
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* Drug: Sequential Gefitinib With Pemetrexed/Platinum
* Drug: Pemetrexed/Platinum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 70 years Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer Presence of at least one index lesion measurable by CT scan or MRI Ecog0-1 Expected life time longer than 12 weeks 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential Gefitinib With Pemetrexed/Platinum<br>Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1 Gefitinib PO. 250mg DAY3-16 | Drug: Sequential Gefitinib With Pemetrexed/Platinum<br> <br> |
| Active Comparator: Pemetrexed/Platinum<br>Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1 | Drug: Pemetrexed/Platinum<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 weeks of non-progression rate |  | from the first cycle of treatment (day one) to two month after the last cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | from the first cycle of treatment (day one) to two month after the last cycle |