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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05466149 | Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion | PHASE2 | ACTIVE NOT_RECRUITING | 100 | — | — | Sep 27, 2022 | Dec 1, 2026 | Nov 19, 2025 | 1 | China |
| NCT04858958 | Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation | PHASE1 | ACTIVE NOT_RECRUITING | 30 | — | — | Aug 10, 2020 | Feb 28, 2026 | Nov 19, 2025 | 1 | China |
Percentage of patients with a confirmed CR or PR relative to the total number of patients.
| Arm | Type | Description |
|---|---|---|
| Furmonertinib 240mg QD | EXPERIMENTAL | Treating patients of locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy. |
| treated subjects will receive Furmonertinib 160mg/day, | EXPERIMENTAL | treated subjects will receive Furmonertinib 160mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability. |
| treated subjects will receive Furmonertinib 240mg/day, | EXPERIMENTAL | treated subjects will receive Furmonertinib 160mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability. |
| treatment-naïve subjects will receive Furmonertinib 240mg/day | EXPERIMENTAL | Treatment naïve patients with EGFR exon 20 insertion mutation positive NSCLC |
| Name | Type | Description |
|---|---|---|
| Furmonertinib | DRUG | 240mg QD on a continuous dosing schedule. |
| Furmonertinib 160mg | DRUG | randomized to 160mg QD |
| Furmonertinib 240mg | DRUG | randomized to 240mg QD |
Inclusion Criteria: * Age ≥ 18 years at time of signing Informed Consent Form * Histologically or cytologically documented, locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy * Documented validated results from local or central testing (as designated by the Sponso...