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Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure
A Randomized, Controlled, Open Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vebreltinib 150mg BID plus PLB1004 80mg QD | Experimental | Subjects will receive Vebreltinib 150mg orally twice per day (BID) plus PLB1004 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. |
|
| Pemetrexed plus cisplatin/carboplatin | Active Comparator | Subjects randomized to the control group will receive pemetrexed 500 mg/m² + platinum-based chemotherapy (carboplatin AUC 5 or cisplatin 75 mg/m²) via intravenous infusion for 4-6 cycles (determined by the investigator) as initial therapy, followed by pemetrexed maintenance therapy (500 mg/m²) until disease progression, intolerable toxicity, initiation of new antitumor therapy, death, loss to follow-up, or other treatment-terminating conditions (whichever occurred first) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vebreltinib | Drug | Subjects will receive Vebreltinib Enteric-coated Capsule orally twice per day (BID). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) by BICR | Progression-free survival (PFS) as assessed by a Blind Independent Center Review Committee (BICR) with reference to RECIST v1.1 for Solid tumors. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) by the investigator | Refer to RECIST v1.1, PFS assessed by the investigator. | 2 years |
| The objective response rate of the tumor (ORR) | Refer to RECIST v1.1, ORR assessed by the investigator and BICR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Lin | Contact | +86-10-84148931 | linliang@avistonebio.com |
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| PLB1004 | Drug | Subjects will receive PLB1004 80mg orally once per day (QD). |
|
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| Pemetrexed plus Carboplatin or Cisplatin | Drug | Subjects randomized to the control group received pemetrexed 500 mg/m² + platinum-based chemotherapy (carboplatin AUC 5 or cisplatin 75 mg/m²) via intravenous infusion for 4-6 cycles (determined by the investigator) as initial therapy, followed by pemetrexed maintenance therapy (500 mg/m²) until disease progression, intolerable toxicity, initiation of new antitumor therapy, death, loss to follow-up, or other treatment-terminating conditions (whichever occurred first). |
|
| 2 years |
| Duration of Response (DoR) | Refer to RECIST v1.1, DoR assessed by the investigator and BICR. | 2 years |
| The disease control rate (DCR) | Refer to RECIST v1.1, DCR assessed by the investigator and BICR. | 2 years |
| Overall Survival (OS) | OS is defined as the time from the date of the first dose until the date of death due to any cause. | 3 years |
| Objective Response Rate (ORR) in subjects with baseline intracranial metastases | Refer to RECIST v1.1，ORR assessed by the investigator and BICR. | 2 years |
| The Disease Control Rate (DCR) in subjects with baseline intracranial metastases | Refer to RECIST v1.1, DCR assessed by the investigator and BICR. | 2 years |
| Duration of Response (DoR) in subjects with baseline intracranial metastases | Refer to RECIST v1.1, DoR assessed by the investigator and BICR. | 2 years |
| Progression-Free Survival (PFS) in subjects with baseline intracranial metastases | Refer to RECIST v1.1, PFS assessed by the investigator and BICR. | 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 |
| Plasma concentrations of Vebreltinib and PLB1004 | Plasma concentrations of Vebreltinib and PLB1004. | 2 years |
| Second progression-free survival (PFS2) | Investigator-assessed second progression-free survival (PFS2). | 2 years |
| Assess the Quality of Healthy Living About Patients（EQ-5D-5L） | Use the EQ-5D-5L scale to measure patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 5 levels: 1= no difficulty, 2= slight difficulty, 3= moderate difficulty, 4= serious difficulty, 5= extremely serious difficulty. The higher the score has the worse the health. Then, the score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy. | 2 years |
| 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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