Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
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Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
160actual
Sites
42
Countries
Australia, Canada, China +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-06-30 | actual | When the study began enrolling |
| Primary completion | 2025-06-03 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2022-05-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Metastatic Non-Small Cell Lung Cancer
- Advanced Non-Small Cell Lung Cancer
- HER2 Exon 20 Mutations
- EGFR Exon 20 Mutations
- EGFR Uncommon Mutations, Including G719X and S768I
Interventions
- Drug: Furmonertinib — also filed as AST2818
- Drug: Furmonertinib — also filed as AST2818
- Drug: Furmonertinib — also filed as AST2818
- Drug: Furmonertinib — also filed as AST2818
- Drug: Furmonertinib — also filed as AST2818
Primary outcomes
what the primary-completion date above is the date OFStage 1: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
measured Up to 36 months after first dose
Stage 2: Overall Response Rate (ORR)
measured Up to 36 months after first dose
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