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Also known as Furmonertinib Mesilate Tablets
Furmonertinib Mesilate · 1 trial · 1 indication
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Randomized Controlled Phase：PFS assessed by BICR based on recist1.1; PFS was defined as the time from the date of randomization to the date of first documented disease progression (assessed according to RECIST v1.1 criteria) or death from any cause, whichever occurred first.
| Arm | Type | Description |
|---|---|---|
| Furmonertinib combined with chemotherapy | EXPERIMENTAL | Furmonertinib Mesilate Tablets+Carboplatin Injection/Cisplatin for injection+Pemetrexed Disodium for Injection |
| Osimertinib Mesylate Tablets | ACTIVE_COMPARATOR | Osimertinib Mesylate Tablets |
| Name | Type | Description |
|---|---|---|
| Furmonertinib Mesilate Tablets | DRUG | Usage and dosage: 80mg, 240mg, or 160mg QD orally Medication duration: A cycle of 21 days until intolerable toxicity, disease progression, death, or initiation of new anti-tumor therapy occurs |
| Carboplatin Injection | DRUG | Usage and dosage: Administer via IV infusion, with a dosage of AUC5, not exceeding 750 mg. Medication schedule: every 3 weeks as a cycle, D1 administration per cycle, immediate administration of carboplatin upon completion of pemetrexed infusion, intravenous infusion, carboplatin can be used for up to 4 cycles. |
| Cisplatin for injection | DRUG | Usage and dosage: Administer via IV infusion at a dose of 75 mg/m2. Medication schedule: Every 3 weeks as a cycle, with D1 administration per cycle. Cisplatin is administered approximately 30 minutes after the infusion of pemetrexed, via intravenous infusion. Adequate hydration therapy must be received before and after cisplatin treatment. Cisplatin can be used for up to 4 cycles. |
| Pemetrexed Disodium for Injection | DRUG | Usage and dosage: Intravenous (IV) infusion administration, dosage of 500 mg/m2 Medication schedule: Administer on the first day of each cycle (21 days per cycle, i.e. every 3 weeks) until intolerable toxicity, disease progression, death, or initiation of new anti-tumor therapy occurs. |
| Osimertinib Mesylate Tablets | DRUG | Usage and dosage: 80mg, QD administration Medication duration: A cycle of 21 days until intolerable toxicity, disease progression, death, or initiation of new anti-tumor therapy occurs |
Inclusion Criteria: 1. Fully understand the trial and voluntarily sign the informed consent form; 2. Age ≥18 years at the time of signing ICF, regardless of gender; 3. Histologically/cytologically confirmed non-squamous NSCLC with brain parenchymal metastases assessed by BICR; Subjects with both br...
Furmonertinib Mesilate is an investigational small molecule being studied for the treatment of patients with non-small cell lung cancer (NSCLC) who have brain metastases. It is specifically being evaluated in patients with EGFR sensitizing mutation-positive non-squamous NSCLC and brain metastases. The drug is currently in Phase 3 clinical development.
Furmonertinib Mesilate targets the epidermal growth factor receptor (EGFR), acting as an inhibitor of this molecular target. By inhibiting EGFR, the drug is designed to interfere with signaling pathways that drive cancer cell growth. This targeted approach is being studied in patients with EGFR sensitizing mutation-positive non-squamous NSCLC and brain metastases.
Furmonertinib Mesilate is being developed by ArriVent BioPharma, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol AVBP. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with EGFR mutation-positive non-squamous NSCLC and brain metastases.
Furmonertinib Mesilate is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug has received Breakthrough Therapy designation from the FDA, which is intended to expedite the development and review of drugs that show promise in treating serious conditions.
Furmonertinib Mesilate is being evaluated in a Phase 3 clinical trial with the identifier NCT06970639. This study is recruiting patients in China and compares furmonertinib plus platinum-based doublet chemotherapy versus osimertinib in patients with EGFR sensitizing mutation-positive non-squamous NSCLC and brain metastases. The trial aims to enroll 380 participants aged 18 years and older.
Yes, Furmonertinib Mesilate is also known as Furmonertinib Mesilate Tablets. The tablet formulation is the pharmaceutical form being used in clinical trials. This alternative name may appear in prescribing information or clinical trial documentation, but both names refer to the same investigational drug being developed by ArriVent BioPharma.