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| Name | Class |
|---|---|
| Wu Jieping Medical Foundation | OTHER |
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This is a multi-center phase III randomized controlled study to assess the efficacy of Gefitinib alone and Gefitinib combination with Pemetrexed/platinum on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR mutation type by intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefitinib and Pemetrexed/platinum | Experimental | Gefitinib 250mg is Taken Orally on day 1-28,combined Pemetrexed (D1)+cisplatin (D1-3) chemotherapy or Pemetrexed (D1)+nedaplatin (D1) chemotherapy, every 28 days |
|
| Gefitinib mono-therapy | Active Comparator | Gefitinib 250mg is Taken Orally everyday |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib and Pemetrexed/platinum | Drug | Gefitinib 250mg is Taken Orally on day 1-28,combined Pemetrexed (D1)+cisplatin (D1-3) or Pemetrexed (D1) + nedaplatin (D1) chemotherapy, every 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| iPFS(intracranial progression free survival | defined as time from randomization to intracranial progressive disease or death. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | proportion of patients with complete or partial response of overall lesions | 2 years |
| intracranial objective response rate (iORR) | proportion of patients with complete or partial response of intracranial lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| li-kun Chen, MD | Contact | 13798019964 | chenlk@sysucc.org.cn | |
| Xue Hou | Contact | 13570569436 | houxue@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University of Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36753281 | Derived | Hou X, Li M, Wu G, Feng W, Su J, Jiang H, Jiang G, Chen J, Zhang B, You Z, Liu Q, Chen L. Gefitinib Plus Chemotherapy vs Gefitinib Alone in Untreated EGFR-Mutant Non-Small Cell Lung Cancer in Patients With Brain Metastases: The GAP BRAIN Open-Label, Randomized, Multicenter, Phase 3 Study. JAMA Netw Open. 2023 Feb 1;6(2):e2255050. doi: 10.1001/jamanetworkopen.2022.55050. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| D000068437 | Pemetrexed |
| D010984 | Platinum |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Gefitinib mono-therapy | Drug | Gefitinib 250mg is Taken Orally everyday |
|
| 2 years |
| PFS(Progression Free Survival) | time from randomization to overall disease progression or death | 2 years |
| OS(Overall Survival) | time from randomization to death from any cause | 3 years |
| adverse events | adverse events were evaluated according to NCI-CTCAE 4.0. | 3 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| 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 |