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To investigate the efficacy of AL2846 capsules in combination with TQB2450 injection or Docetaxel injection in patients with advanced NSCLC who have previously failed immune checkpoint inhibitors (anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody), regardless of new anti-tumor treatment and early termination of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2450 injection + docetaxel injection matching placebo + AL2846 capsules | Experimental | TQB2450 injection combined with docetaxel injection matching placebo and AL2846 capsules 21 days as a treatment cycle. |
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| TQB2450 placebo + docetaxel injection + AL2846 placebo | Active Comparator | TQB2450 placebo combined with docetaxel injection and AL2846 placebo 21 days as a treatment cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2450 injection, docetaxel injection matching placebo, AL2846 capsules | Drug | AL2846 capsules is a multi-targeted small molecule receptor tyrosine kinase inhibitor. TQB2450 Injection is an anti-programmed death-1 (PD-L1). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The time from randomization to the date of death from any cause. | From randomization to the time of death from any cause, assessed up to 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) by investigator assessment | Time from randomization to objective disease progression or death from any cause, whichever occurs first. | From the date of randomization to the date of first recorded progression or death from any cause, whichever comes first, assessed up to 36 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dingzhi Huang, Doctor | Contact | 18622221232 | dingzhi72@163.com | |
| Yi Hu, Doctor | Contact | 13911031186 | huyi0401@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | 230001 | China |
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| TQB2450 placebo, docetaxel injection, AL2846 matching placebo | Drug | Docetaxel injection is a type of chemotherapy for treatment of different types of cancer. |
|
| Objective response rate (ORR) |
Refers to the percentage of subjects with complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. |
| Time from the date of randomization to the first recorded complete remission (CR) or partial remission (PR), assessed up to 36 months. |
| Disease Control Rate (DCR) | Refers to the percentage of subjects with complete response (CR), partial response (PR) or stable disease (SD) ≥ 6 weeks as determined by the investigator according to RECIST 1.1. | Time from randomization date to CR, PR, or SD or 6 weeks, whichever came first. |
| Duration of response (DOR) | For subjects with a best response of complete response (CR) or partial response (PR), it is defined as the time from the date of first documentation of tumor response to the date of first documentation of disease progression or death due to any cause, whichever occurs first. | From the date of first documentation of tumor response to the date of first documentation of disease progression or death due to any cause, whichever occurs first, assessed up to 36 months. |
| 12-month survival rate (12-month OS rate) | The survival curve corresponds to the cumulative survival rate at 12 months | Baseline up to 12-month |
| Health Questionnaire Form | Questionnaire: pain score:Place a check in the space that best reflects patients' health for the day. | During the screening period, the second cycle and other even numbered cycles, each cycle is 21 days, assessed up to 36 months. |
| Effects on subjects' health-related quality of life | Questionnaire: Quality of life related scale (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 3rd edition).For questions 1 to 28, choose a number from 1 to 4, 1 means none and 4 means very good. For questions 29 and 30, choose a number from 1 to 7, with 1 being very poor and 7 being very good. | During the screening period, the second cycle and other even numbered cycles, each cycle is 21 days, assessed up to 36 months. |
| Patients with abnormal laboratory inspection indicators | Laboratory inspection indicators exceed the normal range | From signing the informed consent form to the 30 days after the last dose. |
| Adverse event rate | The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). | From signing the informed consent form to the 30 days after the last dose. |
| Occurrence of anti-drug antibody (ADA) | Occurrence of ADA immunoglobulin | Pre-dose in cycle 1, cycle 2, cycle 5, cycle 9, 90 days after administration, each cycle is 21 days. |
| Occurrence of neutralizing antibody (Nab) | Antibody preventing cells from being invaded by an antigen or infectious agent. | Pre-dose in cycle 1, cycle 2, cycle 5, cycle 9, 90 days after administration, each cycle is 21 days. |
| Peak Concentration (Cmax) | The highest plasma concentration of a drug reached after administration. | 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days. |
| Trough concentration (Cmin) | The lowest concentration of a drug at steady state after multiple doses. | 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days. |
| Peak time | The time it takes for a drug to reach Cmax. | 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days. |
| Area under the drug time curve (AUC) | The area under the curve of drug concentration in blood over time. | 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days. |
| Clearance | It represents the amount of drug cleared per unit of time, reflecting the body's ability to dispose of the drug. | 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days. |
| Apparent volume of distribution (Vd) | Describes the extent of drug distribution in the body. | 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days. |
| The elimination half-life (t1/2) | The time it takes for the drug concentration to drop to half of its original level. | 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days. |
| Cancer Hospital Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| Beijing Friendship Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100050 | China |
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| Beijing Tiantan Hospital Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100070 | China |
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| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100080 | China |
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| Beijing Cancer Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Beijing Chest Hospital Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 101149 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | 400016 | China |
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| Chongqing University Cancer Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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| Three Gorges Hospital Affiliated to Chongqing University | Not yet recruiting | Chongqing | Chongqing Municipality | 404100 | China |
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| Fujian Provincial Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350014 | China |
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| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | 361001 | China |
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| Lanzhou University Second Hospital | Not yet recruiting | Lanzhou | Gansu | 730030 | China |
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| Gansu Provincial Cancer Hospital | Not yet recruiting | Lanzhou | Gansu | 730050 | China |
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| Meizhou People's Hospital | Not yet recruiting | Meizhou | Guangdong | 514031 | China |
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| Cancer Hospital of Shantou University Medical College | Not yet recruiting | Shantou | Guangdong | 515000 | China |
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| Zhongshan City People's Hospital | Not yet recruiting | Zhongshan | Guangdong | 528403 | China |
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| Guigang people's hospital | Not yet recruiting | Guigang | Guangxi | 537100 | China |
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| Liuzhou people's hospital | Not yet recruiting | Liuzhou | Guangxi | 545006 | China |
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| Guangxi Medical University Afiliated Tomor Hospital | Not yet recruiting | Nanning | Guangxi | 530021 | China |
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| Guizhou Provincial People's Hospital | Not yet recruiting | Guiyang | Guizhou | 550002 | China |
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| The Second Affiliated Hospital of Zunyi Medical University | Not yet recruiting | Zunyi | Guizhou | 563006 | China |
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| The Second Affiliated Hospital of Hainan Medical College | Not yet recruiting | Haikou | Hainan | 570216 | China |
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| Hainan Provincial People's Hospital | Not yet recruiting | Haikou | Hainan | 570311 | China |
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| Affiliated Hospital of Hebei University | Not yet recruiting | Baoding | Hebei | 71000 | China |
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| Affiliated Hospital of Chengde Medical College | Not yet recruiting | Chengde | Hebei | 67020 | China |
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| Tangshan People's Hospital | Not yet recruiting | Tangshan | Hebei | 63001 | China |
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| Daqing Oilfield General Hospital | Not yet recruiting | Daqing | Heilongjiang | 163316 | China |
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| Affiliated Cancer Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
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| Jiamusi Tuberculosis Hospital (Jiamusi Cancer Hospital) | Not yet recruiting | Jiamusi | Heilongjiang | 154007 | China |
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| Tong Ji Hospital Affiliated To Tongji Medical College HUST | Not yet recruiting | Wuhan | Hubei | 430030 | China |
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| Hubei Cancer Hospital (HBCH) | Not yet recruiting | Wuhan | Hubei | 430079 | China |
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| Xiangyang Central Hospital | Not yet recruiting | Xiangyang | Hubei | 441021 | China |
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| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410011 | China |
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| The Third Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410013 | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410031 | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410031 | China |
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| The Affiliated Hospital of Inner Mongolia Medical University | Not yet recruiting | Hohhot | Inner Mongolia | 17000 | China |
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| Jiangsu Cancer Hospital | Not yet recruiting | Nanjing | Jiangsu | 210009 | China |
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| Nantong Tumor Hospital | Not yet recruiting | Nantong | Jiangsu | 226361 | China |
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| The Affiliated Hospital of Xuzhou Medical University | Not yet recruiting | Xuzhou | Jiangsu | 221002 | China |
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| XuZhou Central Hospital | Not yet recruiting | Xuzhou | Jiangsu | 221009 | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| The First Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
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| Shenyang Tenth People'S Hospital | Not yet recruiting | Shenyang | Liaoning | 110096 | China |
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| The Second Affiliated Hospital of Xi 'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710004 | China |
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| The First Affiliated Hospital of Air Force Medical University | Not yet recruiting | Xi'an | Shaanxi | 710032 | China |
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| The Second Affiliated Hospital of the Military Medical University of the PLA Air Force | Not yet recruiting | Xi'an | Shaanxi | 710038 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710061 | China |
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| Binzhou Medical University Hospital | Not yet recruiting | Binzhou | Shandong | 256600 | China |
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| Heze Municipal Hospital | Not yet recruiting | Heze | Shandong | 274000 | China |
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| The Second Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | 250000 | China |
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| Shandong Cancer Hospital&Institute | Not yet recruiting | Jinan | Shandong | 250117 | China |
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| Affiliated Hospital of Jining Medical Uniwersity | Not yet recruiting | Jining | Shandong | 272000 | China |
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| Linyi Cancer Hospital | Not yet recruiting | Linyi | Shandong | 276001 | China |
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| Linyi People's Hospital | Not yet recruiting | Linyi | Shandong | 276005 | China |
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| The Affiliated Hospital of Qingdao University | Not yet recruiting | Qingdao | Shandong | 266071 | China |
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| Changzhi People'S Hospital | Not yet recruiting | Changzhi | Shanxi | 46000 | China |
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| Heping Hospital Affiliated to Changzhi Medical College | Not yet recruiting | Changzhi | Shanxi | 46000 | China |
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| Linfen Central Hospital | Not yet recruiting | Linfen | Shanxi | 41000 | China |
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| Shanxi Provincial Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | 30000 | China |
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| Affiliated Hospital of North SIchuan Medical College | Not yet recruiting | Nanchong | Sichuan | 637000 | China |
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| The second people's hospital of neijiang | Not yet recruiting | Neijiang | Sichuan | 641199 | China |
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| TianJin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Tianjin Chest Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300222 | China |
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| Affiliated Tumor Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | 830000 | China |
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| Yunnan Cancer Hospital | Not yet recruiting | Kunming | Yunnan | 650106 | China |
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| The First Affliated Hospital Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310003 | China |
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| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310018 | China |
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| Taizhou Enze Medical Center (Group) | Not yet recruiting | Taizhou | Zhejiang | 318000 | China |
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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 |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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