Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Firmonertinib Mesilate Tablets
Firmonertinib Mesilate · 1 trial · 2 indications
The time from the date of randomization to the date of first documentation of disease progression (assessed according to RECIST v1.1 criteria) or death from any cause, whichever occurred first.
| Arm | Type | Description |
|---|---|---|
| Firmonertinib | EXPERIMENTAL | Oral administration, 240mg, QD。 |
| chemotherapy | ACTIVE_COMPARATOR | Pemetrexed Disodium for Injection： 500mg/m2, intravenous infusion. Cisplatin for injection：75 mg/m2， intravenous infusion. Carboplatin Injection：administered according to the AUC of 5 mg/ml, intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| Firmonertinib Mesilate Tablets | DRUG | Usage and dosage: oral, 240mg, QD。 Medication duration: 21 days as a cycle, until intolerable toxicity, loss of clinical benefit, disease progression (confirmed by BICR), death or other anti-tumor treatment (whichever occurs first). |
| Pemetrexed Disodium for Injection | DRUG | Usage and dosage: 500mg/m2, intravenous infusion. Medication duration: 21 days as a cycle, D1 administration, until the occurrence of intolerable toxicity, loss of clinical benefit, disease progression (confirmed by BICR), death or other anti-tumor treatment (whichever occurs first). |
| Cisplatin for injection | DRUG | Usage and dosage: 75 mg/m2, i.v. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles. |
| Carboplatin Injection | DRUG | Usage and dosage: give the drug according to AUC 5 mg/ml, intravenous drip. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles. |
Inclusion Criteria: 1. Voluntarily sign the informed consent form (ICF). 2. Age ≥18 years at the time of ICF signing. 3. At least one measurable lesion per RECIST v1.1, meeting the following: * No prior local therapy (e.g., radiotherapy) * Not used for biopsy during screening 4. Histological...
Firmonertinib Mesilate is an investigational small molecule being studied for the treatment of advanced non-small cell lung cancer (NSCLC) with EGFR mutations, specifically EGFR PACC or EGFR L861Q mutations. It is currently in Phase 3 clinical development as a first-line treatment.
Firmonertinib Mesilate targets the epidermal growth factor receptor (EGFR), acting as an inhibitor. It is being evaluated in patients with advanced NSCLC who have specific EGFR mutations, including PACC and L861Q mutations, which are biomarkers for patient selection in the ongoing trial.
Firmonertinib 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 a Phase 3 clinical trial for this investigational drug.
Firmonertinib Mesilate is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The FDA has granted it Breakthrough Therapy and Orphan Drug designations for its intended use in EGFR-mutant NSCLC.
Firmonertinib Mesilate is being studied in a Phase 3 trial with the identifier NCT06956001. This randomized, active-controlled trial compares Firmonertinib to platinum-based chemotherapy as first-line treatment for advanced NSCLC with EGFR PACC or EGFR L861Q mutations. The trial is recruiting 300 participants in China.
Yes, Firmonertinib Mesilate is also known as Firmonertinib Mesilate Tablets. The tablet formulation is the oral dosage form being investigated in clinical trials for the treatment of EGFR-mutant advanced non-small cell lung cancer.