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Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and topotecan 1.5mg/m2 IV d1-5. |
|
| Placebo group | Placebo Comparator | Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and topotecan 1.5mg/m2 IV d1-5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | A multi-target receptor tyrosine kinase inhibitor. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) evaluated by IRC | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) evaluated by investigator | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause. | up to 24 months |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YuanKai Shi, Master | Contact | 010-87788293 | syuankaipumc@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100083 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebos |
| Drug |
Anlotinib blank analog capsule. |
|
| Topotecan | Drug | A topoisomerase I inhibitor. |
|
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
| up to 24 months |
| Overall Response Rate (ORR) | Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR). | up to 24 months |
| Disease Control Rate (DCR) | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 24 months |
| Duration of Overall Response (DOR) | The time when the patient first achieved complete or partial remission to disease progression. | up to 24 months |
| PFS rate at month 6 | The percentage of PFS at month 6. | up to 6 months |
| OS rate at month 6 | The percentage of OS at month 6. | up to 6 months |
| OS rate at month 12 | The percentage of OS at month 12. | up to 12 months |
| The efficacy of intracranial lesions | To evaluate the efficacy of of intracranial lesions. | up to 24 months |
| Adverse Event (AE) | Safety data | up to 24 months |
| Serious Adverse Event (SAE) | Safety data | up to 24 months |
| Abnormal laboratory test index | Safety data | up to 24 months |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100083 | China |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |