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The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Non-small cell lung Cancer.
To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Non-small cell lung Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | SHR-A2102+Adebrelimab+Cisplatin/Carboplatin |
|
| Treatment group B | Experimental | SHR-A2102+Adebrelimab+Bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2102 for Injection | Drug | Drug: SHR-A2102 for injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| RP2D | RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages; | through phase IB completion, an average of 1 years |
| Incidence and severity of AE(DLT) | According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose; | from Day1 to 90 days after last dose |
| ORR | efficacy was assessed every 6 weeks within 48 weeks and every 9 weeks after 48 weeks s as determined by RECIST1.1 | 18 months after the last subject was enrolled in the group |
| Measure | Description | Time Frame |
|---|---|---|
| DCR | Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1; | 18 months after the last subject was enrolled in the group |
| DOR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunfei Zhang | Contact | 0518-82342973 | yunfei.zhang.yz277@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese People's Liberation Army General Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Adebrelimab Injection | Drug | Adebrelimab injection. |
|
| Cisplatin injection | Drug | Cisplatin injection. |
|
| Carboplatin injection | Drug | Carboplatin injection. |
|
| Bevacizumab Injection | Drug | Bevacizumab injection. |
|
Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1;
| 18 months after the last subject was enrolled in the group |
| PFS(Investigator evaluation) | Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1; | 18 months after the last subject was enrolled in the group |
| OS(Investigator evaluation) | Since C1D1 and death from any cause; | 18 months after the last subject was enrolled in the group |
| 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 |
|---|---|
| D007267 | Injections |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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