Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a single-arm, open-label, prospective phase II trial. The aim of this phase II study is to evaluate the efficacy and safety of Furmonertinib in patients with EGFR mutation (including 19del or 21L858R or T790M) in advanced NSCLC with brain metastases.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| previously treated | Experimental | advanced NSCLC previously treated with systemic therapy, including chemotherapy and targeted therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furmonertinib 160 mg, Q.D. | Drug | Furmonertinib 160 mg orally once daily in previously treated groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial Progression Free Survival (iPFS) | The time from the first does of the study drugs to the intracranial progression of the disease or death for any reason. | Approximately 18 months after the first patient begin study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial Objective Response Rate (iORR) | Proportion of subjects whose intracranial tumors were assessed as complete response(CR) or partial response(PR) according to mRECIST. | Approximately 12 weeks after the first patient begin study treatment |
| Intracranial Disease Control Rate (iDCR) |
Not provided
Inclusion Criteria:
1.Male or Female aged ≥18 years old; 2.ECOG PS 0-2; 3.Histologically or cytopathologically confirmed non-small cell lung cancer (NSCLC) ; Tumor tissue samples or blood samples are confirmed to be EGFR mutations (including 19del or 21L858R or T790M); 4.Patients with brain metastases previously treated (chemotherapy, TKI), or intracranial progression after brain radiotherapy; 5.Life expectancy >3 months; 6.Without meningeal metastases; 7.According to mRECIST, the subject has at least 1 intracranial measurable lesion (≥ 5mm); 8.Adequate organ function (28 days before enrollment), including:
Exclusion Criteria:
1.Known or suspected allergy to Furmonertinib or other components; 2.With EGFR Ex20ins mutation; 3.Subjects who have received other anti-tumor therapy within four weeks prior to the first dose of the study or who have failed to recover (≤ grade 1) from an adverse event resulting from prior treatment; 4.Any of the following cardiac criteria:
5.Pregnant or breastfeeding women; 6.Known hepatitis C virus (positive HCV Ab) or human immunodeficiency virus (positive HIV antibody) infection, positive HBsAg or HBCAb with positive HBV DNA copy number (>500 IU/ml); 7.Previous interstitial lung disease (ILD); 8.Having severe or uncontrolled systemic disease, including active opportunistic infection or progressive (severe) infection, uncontrolled diabetes, cardiovascular disease (III or IV heart failure by NYHA Functional Classification, second degree or greater atrioventricular block, myocardial infarction or unstable arrhythmia or unstable angina within the past 6 months, cerebral infarction within 3 months, etc.), pulmonary disease (interstitial pneumonia, obstructive pulmonary disease and history of symptomatic bronchospasm); 9.Meningeal metastases. Intracranial metastases with CNS symptoms may be enrolled if the metastases can be adequately treated and CNS symptoms can be restored to a level less than or equal to CTCAE1 and remain stable prior to enrollment; 10.Received a live vaccination within 4 weeks prior to the start of study treatment; 11.Major surgery (excluding diagnostic surgery) within 4 weeks prior to the start of treatment; 12.Known history of mental disease or drug abuse, and currently having an attack or still taking drugs; 13.Serious gastrointestinal dysfunction, or disease that may affect the intake, transportation or absorption of investigational product; 14.History of other malignant tumors within 3 years, except for cured basal cell carcinoma and cervical carcinoma in situ; 15.According to the investigators, subjects with other serious acute or chronic disease, mental disease , laboratory abnormalities that may increase the risk or interfere with the interpretation of study results are excluded; 16.Subjects who are or have been involved in other clinical studies within 4 weeks; 17.According to the investigator, subjects may not complete this study or may not comply with the requirements of this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Junling Li, Professor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ethics Committee | Beijing | 100021 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000705711 | aflutinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Proportion of subjects whose intracranial tumors were assessed as complete response(CR), partial response(PR), or stable disease(SD) according to mRECIST. |
| Approximately 18 months from the first patient begin study treatment |
| Objective Response Rate (ORR) | Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1. | Approximately 12 weeks following the first dose of study drug |
| Disease Control Rate (DCR) | Proportion of subjects whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1. | Approximately 18 months from the first patient begin study treatment |
| Disease progression free survival (PFS) | The time from the first does of the study drugs to the progression of the disease or death for any reason. | Approximately 18 months after the first patient begin study treatment |
| Overall survival (OS) | The time from the first does of the study drugs to the death for any reason. | Approximately 24 months after the first patient begin study treatment |
| 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 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |