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Non-small cell lung cancer has the highest morbidity and mortality in China,and platinum-based chemotherapy is the standard first-line treatment for the wild-type NSCLC,however the overall survival still less than one year.Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit, which has strong effect of anti-angiogenesis.This study is aim to evaluate the efficacy and safety of the combination regimen of anlotinib plus platinum-based chemotherapy as first-line treatment for NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-squamous cell lung cancer | Experimental | Anlotinib combined with pemetrexed and carboplatin, phase I Anlotinib combined with pemetrexed and carboplatin, phase II |
|
| Squamous cell lung cancer | Experimental | Anlotinib combined with paclitaxel and carboplatin, phase I Anlotinib combined with paclitaxel and carboplatin, phase II |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib combined with pemetrexed and carboplatin, phase I | Drug | Non-squamous cell lung cancer, Anlotinib Plus PC This study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus pemetrexed and carboplatin. middle-dose groups: Anlotinib 10mg per day plus pemetrexed and carboplatin. high-dose groups: Anlotinib 12mg per day plus pemetrexed and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival (PFS) | progression free survival | From date of enrollment until the date of first documented progression or date of death from any cause,whichever came first.up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective Response Rate | each 21 days up to the toxicity or PD (up to 24 months) |
| Disease Control Rate (DCR) | Disease Control Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuankai Shi, MD | Contact | +86 13701251865 | syuankaipumc@126.com | |
| Zhaoyuan Shi | Contact | +8615801570739 | szy957@aliyun.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29438373 | Result | Han B, Li K, Zhao Y, Li B, Cheng Y, Zhou J, Lu Y, Shi Y, Wang Z, Jiang L, Luo Y, Zhang Y, Huang C, Li Q, Wu G. Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302). Br J Cancer. 2018 Mar 6;118(5):654-661. doi: 10.1038/bjc.2017.478. Epub 2018 Feb 13. |
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|
|
| Anlotinib combined with paclitaxel and carboplatin, phase I | Drug | Squamous cell lung cancer, Anlotinib plus TC This study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus paclitaxel and carboplatin. middle-dose groups: Anlotinib 10mg per day plus paclitaxel and carboplatin. high-dose groups: Anlotinib 12mg per day plus paclitaxel and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin |
|
|
| Anlotinib combined with pemetrexed and carboplatin, phase II | Drug | Anlotinib: established dose QD PO d1-14, pemetrexed,carboplatin, 21 days per cycle after 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent |
|
|
| Anlotinib combined with paclitaxel and carboplatin, phase II | Drug | Anlotinib :established dose QD PO d1-14, paclitaxel,carboplatin, 21 days per cycle after 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent |
|
|
| each 42 days up to intolerance the toxicity or PD (up to 24 months) |
| Overall Survival (OS) | Overall survival | From enrollment until death (up to 36 months) |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Safety) | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Time Frame: each 21 days up to the toxicity or PD (up to 36 months) |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D017321 | Clinical Trials, Phase I as Topic |
| D017239 | Paclitaxel |
| D017322 | Clinical Trials, Phase II as Topic |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002986 | Clinical Trials as Topic |
| D000068456 | Clinical Studies as Topic |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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