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The purpose of this study is to evaluate the efficacy and safety of Serplulimab Plus Bevacizumab and chemotherapy in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serplulimab+Bevacizumab+Pemetrexed+Carboplatin | Experimental | Using Serplulimab in combination with bevacizumab, carboplatin and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serplulimab | Drug | 300 mg,IV,Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR(Overall Response Rate) | The proportion of subjects who have a complete response (CR) or a partial response (PR) | From start of treatment to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS(Progression Free Survival) | Time from enrollment to first disease progression assessed by investigator or death due to any cause | From start of treatment to 24 months |
| OS(Overall Survival) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhen he | Contact | +86 13523530961 | 13523530961@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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| Bevacizumab Biosimilar HLX04 | Drug | 7.5 mg/kg,Q3W |
|
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| Pemetrexed | Drug | 500 mg/m2,IV,Q3W |
|
| Carboplatin | Drug | AUC=5,IV,Q3W |
|
Time from enrollment to the death of the subject due to any cause
| From start of treatment to 24 months |
| AE(Adverse Event) | incidece of adverse drug event | From start of treatment to 24 months |
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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