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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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Evaluate the efficacy and safety of Anlotinib following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer
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 | Experimental | Anlotinib p.o, qd. Treatment from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) to disease progress or untolerated toxicity or consent withdrawal. The 2:1 ratio (Anlotinib to blank). |
|
| Blank | No Intervention | No intervention from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) .The 2:1 ratio (Anlotinib to blank). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Anlotinib 12mg p.o, qd |
|
|
| 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 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate at 6 months(DCR6) | the percentage of patients with response of Complete Response (CR) or partial response (PR) or stable disease(SD) at least 4 weeks at 6 months after randomization | Estimated to be from baseline up to 3 years |
| Disease Control Rate at 12 months(DCR12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China | ||
| Beijing Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38718190 | Derived | Yang D, Li X, Xue X, Jiang L, Shi A, Zhao J. Anlotinib hydrochloride consolidation after concurrent chemoradiotherapy in stage III non-small-cell lung cancer: a truncated, randomized, multicenter, clinical study (ALTER-L029). Anticancer Drugs. 2024 Aug 1;35(7):680-685. doi: 10.1097/CAD.0000000000001617. Epub 2024 May 3. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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the percentage of patients with response of Complete Response (CR) or partial response (PR) or stable disease(SD) at least 4 weeks at 12 months after randomization |
| Estimated to be from baseline up to 3 years |
| Overall Survival at 12 months (OS12) | the percentage of patients who are alive at 12 months after randomization per the Kaplan-Meier estimate of overall survival at 12 months | Estimated to be from baseline up to 3 years |
| Overall Survival at 24 months (OS24) | the percentage of patients who are alive at 24 months after randomization per the Kaplan-Meier estimate of overall survival at 24 months | Estimated to be from baseline up to 3 years |
| Recurrence rate at 12 months | the percentage of patients with Progressive Disease(PD) at 12 months after randomization | Estimated to be from baseline up to 3 years |
| Recurrence rate at 24 months | the percentage of patients with Progressive Disease(PD) at 24 months after randomization | Estimated to be from baseline up to 3 years |
| Beijing |
| Beijing Municipality |
| 100142 |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| The second hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |