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This study is designed to compare the safety and efficacy of ASKC202 combined with Limertinib Versus platinum-based chemotherapy in locally advanced or metastatic NSCLC With MET Amplification/Overexpression after disease progression on EGFR tyrosine kinase inhibitor.
This is a randomized, controlled, open-label, multicenter, phase 3 clinical study to valuate the efficacy and safety of ASKC202 combined with Limertinib in locally advanced or metastatic NSCLC with MET amplification/overexpression after failure of EGFR inhibitor therapy. Participants will continue to receive treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASKC202 + Limertinib | Experimental | ASKC202+Limertinib |
|
| Pemetrexed + Cisplatin /Carboplatin | Active Comparator | Pemetrexed+Cisplatin/Carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASKC202+ Limertinib | Drug | ASKC202 orally once per day (QD) combined with Limertinib orally BID for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) by BIRC | Progression-free survival (PFS) using BIRC assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).Progression-free survival was defined as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause in the absence of progression (whichever occurred first). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) by investigator | Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).Progression-free survival was defined as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause in the absence of progression (whichever occurred first). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiangsu Aosaikang Study Director | Contact | +86 025 52169999 | ctr-contact@ask-pharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Shanghai | China |
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This is a randomized, controlled, open-label, multicenter, phase 3 clinical study. The primary endpoint of this study is PFS as assessed by BIRC. patients with locally advanced or metastatic NSCLC with MET amplification/Overexpression after failure of EGFR inhibitor therapy are randomly assigned 1:1 stratified by MET amplification (MET GCN≥10 or MET GCN<10 )and brain metastasis (YES or NO) and EGFR mutation type(L858R;Del19) to receive ASKC202+ Limertinib or platinum-based chemotherapy.
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| Pemetrexed + Cisplatin /Carboplatin | Drug | The standard chemotherapy treatment of cisplatin/carboplatin combined with pemetrexed on Day 1of 21 day cycles for 4~6 cycles (every 3 weeks). |
|
| 2 years |
| Overall Survival (OS) | The time from the date of randomization to the date of death . | 3 years |
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) . | 2 years |
| Disease Control Rate (DCR) | DCR was defined as the percentage of participants with complete response(CR), partial response(PR) and stable disease(SD). | 2 years |
| Duration of Response (DoR) | Duration of response was defined as the time from when the criteria for CR or PR were first met to the occurrence of an objective disease progression or death. | 2 years |
| Incidence and severity of treatment-emergent adverse events | Assessed by number and severity of adverse events as recorded on the case report form NCI CTCAE v5.0. | 2 years |
| 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 |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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