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Evaluate the efficacy and safety of Anlotinib plus Pemetrexed as the 1-line treatment of patients with Platinum intolerant advanced non-squamous NSCLC, with Pemetrexed control.
Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration(SFDA:2011L00661) which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib plus Pemetrexed | Experimental | Anlotinib plus Pemetrexed |
|
| Pemetrexed | Other | Pemetrexed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib plus Pemetrexed | Drug | Anlotinib p.o, qd and it should be continued until disease progress or unacceptable toxic effects. Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients alive and progression free at 6 months (APF6) | the number (%) of patients who are alive and progression free per RECIST 1.1 at 6 months after randomization per Kaplan-Meier estimate of progression free survival at 6 months. | Estimated to be from baseline up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival(PFS) | the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression) | Estimated to be from baseline up to 2 years |
| Overall Survival(OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoqing Liu | Contact | 86-010-89509324 | liuxiaoqing@csco.org.cn | |
| Shucai Zhang | Contact | 86-010-89509324 | sczhang6304@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chest Hospital | Recruiting | Beijing | Beijing Municipality | 101149 | China |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Pemetrexed | Drug | Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects |
|
the time from randomization to death from any cause
| Estimated to be from baseline up to 2 years |
| Disease Control Rate(DCR) | the total proportion of patients who demonstrate a response(complete responses + partial responses + stable disease ) to treatment | Estimated to be from baseline up to 2 years |
| Objective Response Rate(ORR) | the total proportion of patients who demonstrate a response(complete responses + partial responses) to treatment | Estimated to be from baseline up to 2 years |
| 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 |