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This is a multiple-arm, open phase II clinical trial evaluating the safety, tolerability,and preliminary efficacy of JS207 in NSCLC after progression following Platinum-based chemotherapy and immunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w. |
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| Arm B | Experimental | Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w. |
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| Arm C | Experimental | Patients receive JS207 10mg/kg or other dosage . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS207 injection +docetaxel | Drug | Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w. |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate objective response rate (ORR) | 1.5years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate disease control rate (DCR) | 2years |
| Duration of response (DOR) |
| Measure | Description | Time Frame |
|---|---|---|
| the trough concentrations (PK) | to characterize the tough concentration of JS207&JS004 | 1.5years |
| Neutralizing antibody(Nab) | to characterize the neutralizing antibody of JS207&JS004 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojun Wang, Master | Contact | 021-50796193 | xiaojun_wang@junshipharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chest Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 101100 | China |
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| JS207 injection +JS004 injection | Drug | Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w. |
|
| JS207 injection | Drug | Patients receive JS207 10mg/kg or other dosage. |
|
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate duration of response (DOR)
| 2years |
| Progression-free survival (PFS) | According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate progression-free survival (PFS) | 1.5years |
| Overall survival (OS) | To evaluate overall survival (OS) | 2years |
| AE | Incidence and serverity of adverse events(AE),abnormal changes in laboratory and other tests with clinical significance | 2years |
| Abnormal changes in laboratory | Incidence and serverity of abnormal changes in laboratory and other tests with clinical significance | 2years |
| 1.5years |
| Antidrug antibodies (ADA) | to characterize antidrug antibodies of JS207&JS004 | 1.5years |
| Jilin Cancer Hospital | Recruiting | Jilin City | Changchun | 130012 | China |
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| Hunan Cancer Hospital | Recruiting | Hunan | Changsha | 410031 | China |
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| West China Hospital, Sichuan University | Recruiting | Sichuan | Chengdu | 610044 | China |
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| Second Affiliated Hospital, PLA Academy of Military Medical Sciences | Recruiting | Chongqing | Chongqing Municipality | 400037 | China |
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| Army Medical Center, PLA | Recruiting | Chongqing | Chongqing Municipality | 400042 | China |
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| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangdong | Guangzhou | 510120 | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Heilongjiang | Harbin | 150081 | China |
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| Anyang Tumor Hospital | Recruiting | Anyang | Henan | 455000 | China |
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| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | Henan | 471003 | China |
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| The First Affiliated Hospital of Xinxiang Medical University | Recruiting | Xinxiang | Henan | 453100 | China |
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| The First People's Hospital of Changde | Recruiting | Changde | Hunan | 415003 | China |
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| The First Affiliated Hospital of Nanchang University | Recruiting | Jiangxi | Nanchang | 330000 | China |
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| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| The Third People's Hospital of Datong | Recruiting | Datong | Shanxi | 037008 | China |
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| Yibin Second People's Hospital | Recruiting | Yibin | Sichuan | 644000 | China |
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| Affiliated Tumor Hospital of Xinjiang Medical University | Recruiting | Xinjiang | Xinjiang | 830011 | China |
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| Shanghai Pulmonary Hospital | Not yet recruiting | Shanghai | 200433 | China |
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