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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.
Patients will be randomized to 2 groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential Gefitinib With Pemetrexed/Platinum | Experimental | Pemetrexed IV 500 mg/m2 ,DAY2 DDP IV 75mg/m2 ,DAY1 OR CAP IV AUC 5,DAY1 Gefitinib PO. 250mg DAY3-16 |
|
| Pemetrexed/Platinum | Active Comparator | Pemetrexed IV 500 mg/m2 ,DAY2 DDP IV 75mg/m2 ,DAY1 OR CAP IV AUC 5,DAY1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequential Gefitinib With Pemetrexed/Platinum | Drug |
| ||
| Pemetrexed/Platinum |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | from the first cycle of treatment (day one) to two month after the last cycle |
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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:
Signed written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang jian hua, MD,PhD | Cancer hospital Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D010984 | Platinum |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Drug |
|
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |