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This study evaluates the efficacy and safety of Firmonertinib 160 mg once daily in patients with EGFR-mutant, advanced NSCLC who achieve stable disease after first-line Firmonertinib 80 mg for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Firmonertinib 160mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firmonertinib 160mg | Drug | Patients enter an 8-week induction phase at 80 mg once daily. Those with stable disease per RECIST v1.1 at Week 8 escalate to 160 mg daily until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Percentage of patients achieving CR or PR per RECIST v1.1. | From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Time from the start of randomization (or the start of treatment in a single-arm trial) to tumor progression or death from any cause, whichever occurs first. | From first dose to disease progression or death, whichever occurs first; followed for up to 24 months. |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sen Han, MD | Contact | 010-88121122 | handsomehansen1@126.com |
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Percentage of patients achieving CR, PR, or SD.per RECIST v1.1. |
| From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months. |
| Duration of Response (DoR) | Duration from first response to progression or death. | From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months. |
| CNS Objective Response Rate (CNS-ORR) | Evaluated via CNS imaging per RECIST v1.1 or applicable CNS criteria. | From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months. |
| Incidence of Treatment-related adverse event (TRAE) | any adverse event that in the investigator's opinion may have been caused by the study medication with reasonable possibility per CTCAE 5.0. | From first dose of therapy through 30 days after last dose of study treatment up to 24 months. |
| 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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