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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07185997 | Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations | PHASE3 | RECRUITING | 480 | — | — | Dec 17, 2025 | Dec 1, 2030 | Jun 8, 2026 | 74 | United States, Australia +13 |
PFS is defined as the time from randomization to the first occurrence of disease progression as determined by BICR using RECIST v1.1, or death from any cause, whichever occurs first.
Confirmed ORR is defined as the percentage of participants with a confirmed CR or PR based on BICR assessment relative to the total number of participants.
| Arm | Type | Description |
|---|---|---|
| Firmonertinib 240 mg | EXPERIMENTAL | - |
| EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choice | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Firmonertinib | DRUG | 240 mg oral, daily firmonertinib tablet |
| EGFR-TKI inhibitor based on investigator's choice | DRUG | osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet |
Key Eligibility Criteria: * Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy. * Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissu...