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| Name | Class |
|---|---|
| Allist Pharmaceuticals, Inc. | INDUSTRY |
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This is a phase II study aimed to assess the efficacy and safety of furmonertinib, a third generation EGFR TKI, as perioperation therapy in stage IIIA-IIIB (N1-N2) resectable NSCLC patients.
Please refer to detailed description in the following context.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furmonertinib | Experimental | Furmonertinib as perioperation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furmonertinib | Drug | Furmonertinib 80mg/d as neoadjuvant therapy for 8 weeks before surgery, then as adjuvant therapy for 3 years after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Proportion of patients whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1 | Approximately 8 weeks following the first dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | Proportion of patients whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1 | Approximately 8 weeks following the first dose of study drug |
| Progression free survival (PFS) |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating tumor DNA clearance rate | The proportion of patients with circulating tumor DNA clearance after neoadjuvant therapy | Approximately 8 weeks following the first dose of study drug |
| Minimal residual disease rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changli Wang, MD | Contact | +86 022-23340123 | aswindcc@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Changli Wang, MD | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
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The IPD sharing plan is not to be shared according to the policy.
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| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000705711 | aflutinib |
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The time from the first does of the study drugs to the progression of the disease or death for any reason.
| Approximately 3 years following the first dose of study drug |
| Disease free survival (DFS) | The time from the end of surgery to the progression of the disease or death for any reason. | Approximately 3 years following the first dose of study drug |
| Adverse Events (AEs) | The number of patients with adverse events and the severity according to CTCAE v5.0 | From the start of study drug to 28 days after the last dose of study drug |
The proportion of patients with minimal residual disease defined as detectable ctDNA with a variant allele fraction of at least 0.1% in plasma after surgery
| Approximately 12 weeks following the first dose of study drug |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |