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This is a multi-center phase 3 randomized controlled study to assess the efficacy of Pemetrexed/platinum with or without Bevacizumab on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR/ALK wild type by intracranial PFS(iPFS), also PFS ,ORR, DCR and OS. The safety is evaluated as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab plus Pemetrexed/platinum | Experimental | bevacizumab (7.5mg/kg, intravenously on day 1 of each 3-week cycle) plus pemetrexed-platinum chemotherapy (pemetrexed 500mg/m2 combined with cisplatin 75mg/m2 or nedaplatin 80mg/m2 intravenously on day 1 of each 3-week cycle) for four to six cycles, followed by bevacizumab plus pemetrexed maintenance every 3 weeks. |
|
| Pemetrexed/platinum | Active Comparator | pemetrexed 500mg/m2 combined with cisplatin 75mg/m2 or nedaplatin 80mg/m2 intravenously on day 1 of each 3-week cycle for four to six cycles, followed by pemetrexed maintenance every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed/Platinum | Drug | pemetrexed 500mg/m2 combined with cisplatin 75mg/m2 or nedaplatin 80mg/m2 intravenously on day 1 of each 3-week cycle for four to six cycles, followed by pemetrexed maintenance every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare iPFS(intracranial progression free survival) in two arms | 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate(CR&PR) | 3 years | |
| safety | adverse events (AEs) were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| PFS: progress free survival | 3 years | |
| OS: overall survival | 3 years |
Inclusion Criteria:
Exclusion criteria:
Patients who meet any of the following exclusion criteria are not eligible for this trial:
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| Name | Affiliation | Role |
|---|---|---|
| li-kun Chen, Doctor | Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University of Cancer Center | Guangzhou | Guangdong | 510060 | China |
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| Bevacizumab and Pemetrexed/platinum | Drug | bevacizumab (7.5mg/kg, intravenously on day 1 of each 3-week cycle) plus pemetrexed-platinum chemotherapy (pemetrexed 500mg/m2 combined with cisplatin 75mg/m2 or nedaplatin 80mg/m2 intravenously on day 1 of each 3-week cycle) for four to six cycles, followed by bevacizumab plus pemetrexed maintenance every 3 weeks. |
|
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D010984 | Platinum |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | 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 |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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