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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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Anlotibib (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 VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to evaluate the efficacy and safety of sequential anlotinib followed by EP regimen plus concurrent radiotherapy for unresectable stage III non-small cell lung cancer(NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anlotinib and chemoradiotherapy | Experimental | anlotinib: 12 mg, po, qd, on day1-14 of a 21 days cycle; anlotinib will be administrated to 2 cycles for induction before the 2 cycles of chemoradiation and anlotinib will be administrated up to 1year or disease progression for maintenance treatment. EP regimen: cisplatin 50mg/m2, d1, 8, 29, 36; etoposide 50mg/m2, d1~5, d29~33. Radiotherapy program: 2 Gy / time / d, 5 d / week;PTV radiotherapy 60~66Gy/30~33 times/6~7 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib Hydrochloride | Drug | anlotinib once daily on days 1-14 of 21days cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival (PFS) | Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) | Approximately 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The recurrence rate in 12-month | The proportion of patients with disease progression within 12 months of the initiation of consolidation treatment with anlotinib. | 12 months. |
| The recurrence rate in 24-month |
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Inclusion Criteria:
Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
≥ 18 and ≤ 70 years of age within male and female.
Histologically confirmed,locally advanced NSCLC of stage IIIA/IIIB.
Unresectable stage IIIA and stage IIIB with pathological evidence of the following images or lymph nodes:
Life expectancy of more than 3 months.
Eastern Cooperative Oncology Group(ECOG)performance scale 0-1.
Weight loss ≤5% in the last 3 months since enrollment.
Good lung function (predicted FEV1 ≥1 liter), no history of bronchial pneumonia, tracheobronchial disease and upper respiratory tract bleeding.
None previous chemotherapy or targeted therapy.
Adequate hepatic, renal, heart, and hematologic functions (Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 100×109/L, Hemoglobin(HB) ≥ 90 g/L, total bilirubin within 1.5×the upper limit of normal(ULN), and serum transaminase≤2.5×the Upper Limit Of Normal(ULN), serum creatine ≤ 1.25 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥ 45ml/min.
For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.
Exclusion Criteria:
small cell lung cancer (including small cell and non-small cell mixed lung cancer).
Radiologically documented evidence of tumor lesions from large vessels ≤ 5mm or major blood vessel invasion or encasement by cancer; Obvious cavity or necrosis formed in the tumor.
History and complication:
Physical examination and laboratory inspection:
At the discretion of the investigator, the patient may have other factors that may cause the study to be terminated midway, such as other serious illnesses or serious laboratory abnormalities or other safety that may affect the subject, or test data and samples. Factors such as family or society collected.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dehua Wu | Contact | 020-61642136 | 331576705@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | China |
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The proportion of patients with disease progression within 24 months of the initiation of consolidation treatment with anlotinib.
| 12 months. |
| The disease control rate in 6-month | The proportion of CR, PR, and SD within 6 months of the initiation of consolidation treatment with anlotinib. | 6 months. |
| The disease control rate in 12-month | The proportion of CR, PR, and SD within 12 months of the initiation of consolidation treatment with anlotinib. | 12 months. |