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A randomized, double-blind, controlled, multicenter phase III study of TQB2450 or placebo combined with Anlotinib, etoposide and carboplatin versus Etoposide and Carboplatin in subjects with extensive small cell lung cancer. The primary outcome measures include PFS and OS. Extended stage Small Cell Lung Cancer (SCLC) patients will be registered, after signing the informed consent, and then centrally randomized 1:1:1 to the experimental arms and the control arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2450+Anlotinib+ etoposide + carboplatin | Experimental | Induced stage:TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules 12 mg 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) +Etoposide (100mg/m2 IV continuously on Day 1, 2 and 3)+Carboplatin(AUC 5 mg/mL/min IV on Day 1( maximum dosage: 800 mg)) maintenance stage:TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules 12 mg 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) |
|
| TQB2450(blank)+Anlotinib+ etoposide + carboplatin | Experimental | Induced stage:TQB2450 (blank) 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules 12 mg 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) +Etoposide (100mg/m2 IV continuously on Day 1,2 and 3)+ Carboplatin(AUC 5 mg/mL/min IV on Day 1( maximum dosage: 800 mg)) maintenance stage:TQB2450 (blank) 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules 12 mg 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) |
|
| TQB2450(blank)+Anlotinib(blank)+ etoposide + carboplatin | Active Comparator | Induced stage:TQB2450 (blank) 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib (blank) capsules 12 mg 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) +Etoposide (100mg/m2 IV continuously on Day 1,2 and 3)+Carboplatin(AUC 5 mg/mL/min IV on Day 1( maximum dosage: 800 mg)) maintenance stage:TQB2450 (blank) 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules (blank) 12 mg 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2450 | Drug | TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause. | up to 12 months |
| Overall survival (OS) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) . | up to 12 months |
| Disease control rate (DCR) | Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Cheng, doctor | Contact | 0431-85873390 | jl.cheng@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38992123 | Derived | Cheng Y, Chen J, Zhang W, Xie C, Hu Q, Zhou N, Huang C, Wei S, Sun H, Li X, Yu Y, Lai J, Yang H, Fang H, Chen H, Zhang P, Gu K, Wang Q, Shi J, Yi T, Xu X, Ye X, Wang D, Xie C, Liu C, Zheng Y, Lin D, Zhuang W, Lu P, Yu G, Li J, Gu Y, Li B, Wu R, Jiang O, Wang Z, Wu G, Lin H, Zhong D, Xu Y, Shu Y, Wu D, Chen X, Wang J, Wang M, Yang R. Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial. Nat Med. 2024 Oct;30(10):2967-2976. doi: 10.1038/s41591-024-03132-1. Epub 2024 Jul 11. |
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| Anlotinib | Drug | a multi-target receptor tyrosine kinase inhibitor |
|
| Etoposide | Drug | Etoposide is a cell cycle-specific antitumor drug |
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| Carboplatin | Drug | Carboplatin is cell cycle nonspecific antitumor drug |
|
| TQB2450(blank) | Drug | Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day |
|
| Anlotinib(blank) | Drug | Subjects administrated anlotinib (blank) 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) |
|
| up to 12 months |
| Duration of response(DOR) | For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. | up to 12 months |
| PFS rate of 6 and 12 months progression-free survival | PFS rate of progression-free survival at 6 and 12 months: the percentage of subjects who did not develop disease progression or die of any cause at 6 and 12 months after randomization. | up to 12 months |
| OS rate of 12 and 18 months total survival | Total survival OS rate at 12 and 18 months: the proportion of subjects who died of any cause at 12 and 18 months after randomization. | up to 12 months |
| Quality of life score | up to 12 months |
| Incidence and severity of adverse events (AE) and serious adverse events (SAE) | Security Index | up to 24 months |
| Anhui chest hospital | Hefei | Anhui | 230001 | China |
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| AnHui Provincial Hospital | Hefei | Anhui | 230001 | China |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230001 | China |
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| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230001 | China |
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| Beijing chest hospital,capital medical university | Beijing | Beijing Municipality | 101149 | China |
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| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
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| Fujian Provincial Cancer Hospital | Fuzhou | Fujian | 350011 | China |
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| Lanzhou University Second Hospital | Lanzhou | Gansu | 730030 | China |
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| Gansu Provincial Cancer Hospital | Lanzhou | Gansu | 730050 | China |
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| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
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| The Fiest Affiliated Hospital of Guanghzou University of Chinese Medicine | Guangzhou | Guangdong | 510405 | China |
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| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
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| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | 524000 | China |
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| Guangxi Medical University Affiliated Tumor Hospital | Nanning | Guangxi | 530000 | China |
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| Guizhou Provincial people's Hospital | Guiyang | Guizhou | 550002 | China |
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| The Second Affiliated Hospital of Hainan Medical University | Haikou | Hainan | 570100 | China |
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| Shijiazhuang First Hospital | Shijiazhuang | Hebei | 050011 | China |
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| Hebei Chest Hospital | Shijiazhuang | Hebei | 050048 | China |
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| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
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| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
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| Jinzhou Central Hospital | Jinzhou | Hubei | 434020 | China |
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| Hunan Cancer Hospital | Changsha | Hunan | 410006 | China |
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| The First People's Hospital of Lianyungang | Lianyungang | Jiangsu | 222000 | China |
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| Jilin Cancer Hospital | Changchun | Jilin | 130000 | China |
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| The Second Hospital of Dalian Medical University | Dalian | Liaoning | 116027 | China |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D005047 | Etoposide |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
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