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An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Combination with Chemotherapy or Monotherapy in Advanced Non-squamous Non-small Cell Lung Cancer (nsqNSCLC) Patients with High EGFR Expression
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX07+carboplatin+pemetrexed | Drug | HLX07 1500mg q3w+carboplatin+pemetrexed |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1) | up to 2 years |
| PFS | Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival | from the date of first dose until the date of death from any cause,assessed up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| baohui han, phD | Contact | 021-22200000 | hanxkyy@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| C000722210 | HLX07 |
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| HLX07+docetaxel | Drug | HLX07 1500mg q3w+docetaxel |
|
| HLX07 | Drug | HLX07 1500mg q3w |
|