Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the effects and safety of Anlotinib with placebo in patients with small cell lung cancer(SCLC).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib | Experimental | Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle |
|
| Placebo | Placebo Comparator | Placebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival (PFS) | From randomization,each 42 days up to PD or death(up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From randomization until death (up to 24 months) | |
| Objective Response Rate (ORR) | each 42 days up to intolerance the toxicity or PD (up to 24 months) | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients who have been used anlotinib
Patients who have been used targeted drugs(such as sunitinib,bevacizumab,endostar),Immune targeted drugs
4 weeks or less from the last cytotoxic therapy, radiation therapy or surgery
Patients whose primary lesion with active bleeding within 4 months
Carcinomatous meningitis
Patients who known to the central nervous system
Patients with factors that could affect oral medication (such as dysphagia,chronic diarrhea, intestinal obstruction etc.)
Patients with any severe and/or unable to control diseases,including:
Patients with non-healing wounds or fractures
Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism
Patients with drug abuse history and unable to get rid of or Patients with mental disorders
Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage
History of immunodeficiency
Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34417989 | Derived | Gong J, Wan Q, Shang J, Qian X, Su D, Sun Z, Liu G. Cost-Effectiveness Analysis of Anlotinib as Third- or Further-Line Treatment for Relapsed Small Cell Lung Cancer (SCLC) in China. Adv Ther. 2021 Oct;38(10):5116-5126. doi: 10.1007/s12325-021-01889-2. Epub 2021 Aug 21. | |
| 34302324 | Derived | Zhang C, Wang J, Wang X, Meng Z, Cheng Y, Li K. Peripheral blood indices to predict PFS/OS with anlotinib as a subsequent treatment in advanced small-cell lung cancer. Cancer Biol Med. 2021 Jul 24;19(8):1249-58. doi: 10.20892/j.issn.2095-3941.2020.0727. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625192 | anlotinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle |
|
| Disease Control Rate (DCR) |
| each 42 days up to intolerance the toxicity or PD (up to 24 months) |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Until 30 day safety follow-up visit (up to 24 months) |
| The 307th Hospital of Chinese People's Liberation Army |
| Beijing |
| Beijing Municipality |
| 100071 |
| China |
| Guangdong General Hospital | Guangzhou | Guangdong | 510080 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
| Harbin medical university affiliated tumor hospital | Harbin | Heilongjiang | 150081 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410006 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130012 | China |
| Liaoning Cancer Hospital | Shenyang | Liaoning | 110042 | China |
| Linyi Cancer Hospital | Linyi | Shandong | 276000 | China |
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| Tianjin Medical University Cancer Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| 34006926 | Derived | Cheng Y, Wang Q, Li K, Shi J, Liu Y, Wu L, Han B, Chen G, He J, Wang J, Lou D, Yu H, Wang S, Qin H, Li X. Anlotinib vs placebo as third- or further-line treatment for patients with small cell lung cancer: a randomised, double-blind, placebo-controlled Phase 2 study. Br J Cancer. 2021 Aug;125(3):366-371. doi: 10.1038/s41416-021-01356-3. Epub 2021 May 18. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |