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To evaluate the tolerability and safety of SHR-8068 in combination with adebrelimab in subjects with advanced NSCLC To evaluate the efficacy of SHR-8068 in combination with adebrelimab and platinum-based chemotherapy in subjects with advanced NSCLC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-8068 in combination with adebrelimab | Experimental |
| |
| SHR-8068 in combination with adebrelimab and platinum-based chemotherapy | Experimental |
| |
| Adebrelimab in combination with platinum-based chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-8068;Adebrelimab | Drug | SHR-8068: Sterile Injection, 50mg/10mL, Intravenous Infusion Adebrelimab: injection, 600mg/12mL, intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity | The observation period is 21 days after the first dose | |
| Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points; | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate, determined using RECIST v1.1 criteria | up to 2 years | |
| Progression-Free-Survival assessed by investigator | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Xu | Contact | 0518-82342973 | xin.xu@hengrui.com | |
| Weixia Li | Contact | 0518-82342973 | weixia.li@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Chest Hospital | Not yet recruiting | Hefei | Anhui | 230000 | China |
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This study is a multicenter, open-label, dose-finding and efficacy-expansion phase Ib/II study. The first stage is for dose finding, using modified 3+3 design; the second stage is for dose confirmation and efficacy expansion through randomization.
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| SHR-8068;adebrelimab and platinum-based chemotherapy | Drug | SHR-8068: Intravenous Infusion Adebrelimab: injection, intravenous infusion Pemetrexed disodium for injection: , intravenous drip Paclitaxel for injection (albumin-bound): intravenous drip Paclitaxel injection: intravenous drip Carboplatin injection: intravenous drip Cisplatin injection: intravenous drip |
|
| Adebrelimab;platinum-based chemotherapy | Drug | Adebrelimab: intravenous infusion Pemetrexed disodium for injection: intravenous drip Paclitaxel for injection (albumin-bound): intravenous drip Paclitaxel injection: intravenous drip Carboplatin injection: intravenous drip Cisplatin injection: intravenous drip |
|
| Anhui Provincial Hospital | Not yet recruiting | Hefei | Anhui | 230000 | China |
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| West China Hospital Of Sichuan University | Not yet recruiting | Chengdu | Chengdu | 610000 | China |
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| Cancer Hospital Affiliated to Chongqing University | Not yet recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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| The First Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | 530022 | China |
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| Guizhou Provincial People's Hospital | Not yet recruiting | Guiyang | Guizhou | 550002 | China |
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| Affiliated Hospital of Zunyi Medical University | Not yet recruiting | Zunyi | Guizhou | 563003 | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
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| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
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| Xiangyang Central Hospital | Not yet recruiting | Xiangyang | Hubei | 441000 | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410000 | China |
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| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| Affiliated Hospital of Jiangnan University | Not yet recruiting | Wuxi | Jiangsu | 214000 | China |
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| North Jiangsu People's Hospital | Not yet recruiting | Yangzhou | Jiangsu | 225001 | China |
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| Jilin Cancer Hospital | Not yet recruiting | Changchun | Jilin | 130103 | China |
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| Affiliated Tumor Hospital of Shandong First Medical University | Not yet recruiting | Jinan | Shandong | 250000 | China |
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| Yunnan Cancer Hospital | Not yet recruiting | Kunming | Yunan | 650106 | China |
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| ID | Term |
|---|---|
| D017671 | Platinum Compounds |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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