Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Firmonertinib · 2 trials · 8 indications
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.
DFS as assessed by the investigator in Stage II- IIIB. DFS defined as the time from the date of randomization to the first observation of disease recurrence (by pathological diagnosis or imaging) or death caused by any reason, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Firmonertinib 240 mg | EXPERIMENTAL | - |
| EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choice | ACTIVE_COMPARATOR | - |
| Firmonertinib | EXPERIMENTAL | Firmonertinib: 240 mg, QD, orally |
| Placebo | PLACEBO_COMPARATOR | Placebo: 240 mg, QD, orally |
| 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 |
| Placebo | DRUG | Placebo: 240 mg, QD, orally |
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...
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