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Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
A Multicenter,Randomized,open-label,Phase II Study to Evaluate the Efficacy and Safety of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients with EGFRm+(exon 19 deletion or exon 21 L858R)/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vebreltinib 150mg BID+PLB1004 80mg QD | Experimental | Subjects will receive Vebreltinib 150mg orally twice per day (BID) + PLB1004 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. |
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| Osimertinib 80mg QD | Active Comparator | Subjects will receive Osimertinib 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vebreltinib | Drug | Subjects will receive Vebreltinib orally twice per day (BID). |
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| Measure | Description | Time Frame |
|---|---|---|
| The objective response rate of the tumor (ORR) | The incidence of confirmed complete response or partial response. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| The disease control rate (DCR) | The incidence of complete response, partial response and stable disease. | 2 Years |
| Duration of Response (DoR) | The duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Lin | Contact | 08-10-84148931 | linliang@avistonebio.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi long Wu, MD | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| C000596361 | osimertinib |
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| Osimertinib | Drug | Subjects will receive Osimertinib 80mg orally once per day (QD). |
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| PLB1004 | Drug | Subjects will receive PLB1004 80mg orally once per day (QD). |
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| 2 Years |
| Progression-free survival (PFS) | Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). | 2 Years |
| Time to Response (TTR) | The period from the date of randomization to the date when the criteria for complete response or partial response was first measured (first record shall prevail). | 2 Years |
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events (TEAEs),A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | 2 Years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |