Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06956001 | Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation | PHASE3 | RECRUITING | 300 | — | — | Nov 19, 2024 | Jul 1, 2028 | Feb 12, 2026 | 2 | China |
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...