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This study is a multicenter, open-label, dose-finding/efficacy-expanding Phase IB/II clinical trial to evaluate SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer. The study consists of two phases: Phase IB to explore the safety/tolerability of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer; Phase II: To explore the efficacy of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A2102 in Combination with Adebrelimab and SHR-8068 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2102 | Drug | SHR-A2102: injection, 80mg/ bottle, intravenous drip |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Recommended Phase II dose (RP2D) | From first dose of study treatment until the end of Cycle 1（up to 21 days） | |
| Objective Response Rate (ORR) | The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria. | From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months) |
| Incidence and severity of AEs | The observation period ended at the end of the 21-day period after the first dose of SHR-A2102 or Adebrelimab or SHR-8068 (up to 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | The percentage of participants who have a best objective response of confirmed CR or PR or who have SD after start of treatment. | From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months) |
| Duration of Response (DoR) |
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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 | |
| Yunfei Zhang | Contact | 0518-82342973 | yunfei.zhang.yz277@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Adebelimab (SHR-1316) | Drug | Adebelimab (SHR-1316): injection, 600mg(12mL)/ bottle, intravenous drip |
|
| SHR-8068 | Drug | SHR-8068: injection, 50mg（10mL）/ bottle, intravenous drip |
|
The time from the date of first response until date of disease progression or death in the absence of disease progression. |
| From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)] |
| Progression free Survival (PFS) | Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death. | From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months) |
| Overall Survival (OS) | The time until death due to any cause. | From time of first dose of objective disease progression until the date of death (up to 24 months) |
| 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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