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| Name | Class |
|---|---|
| The General Hospital of Eastern Theater Command | OTHER |
| Shanghai Chest Hospital | OTHER |
| Fujian Provincial Hospital | OTHER |
| Shanghai Changzheng Hospital |
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This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until disease progression, intolerable toxic side effects, or Subjects voluntarily withdrew informed consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Furmonertinib 160mg QD | Experimental | Furmonertinib (AST2818) 160mg QD. All patients enrolled into this group will receive furmonertinib 160mg daily. |
|
| Group B: Furmonertinib 240mg QD | Experimental | Furmonertinib (AST2818) 240mg QD. All patients enrolled into this group will receive furmonertinib 240mg daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furmonertinib | Drug | Drug: Furmonertinib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Objective Response Rate (ORR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments) is defined as the number (%) of patients with response | Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable Response Evaluation Criteria in Solid Tumors (RECIST) assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | The number of patients with adverse events and the severity according to CTCAE v5.0. | From the start of study drug to 30 days after the last dose of study drug |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | China |
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| OTHER |
| The First Affiliated Hospital of Bengbu Medical University | OTHER |
| The First People's Hospital of Changzhou | OTHER |
| Second Affiliated Hospital of Wannan Medical College | OTHER |
Parallel Assignment
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| The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 12 months after the first patient begin study treatment |
| Disease Control Rate (DCR) | Disease control rate (DCR) is defined as the percentage of subjects who have a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator. | Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment |
| Duration of Response (DoR) | Duration of Response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression. | Duration of Response analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 12 months from the first patient begin study treatment |
| 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 |
|---|---|
| C000705711 | aflutinib |
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