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
← catalyst calendarNCT07185997 · readout ≤ 923 d
Sponsored by ArriVent BioPharma, Inc. (industry) · AVBP — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
480estimated
Sites
88
Countries
Australia, Canada, France +13
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 | 2025-12-17 | actual | When the study began enrolling |
| Primary completion | Feb 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2025-09-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-03 | 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
- Metastatic Non-Small-Cell Lung Cancer
- Advanced Non-Small-Cell Lung Cancer
- EGFR P-Loop and Alpha C-Helix Compressing
- EGFR PACC
- EGFR Uncommon Mutations
Interventions
- Drug: Firmonertinib — also filed as AST2818
- Drug: EGFR-TKI inhibitor based on investigator's choice
Primary outcomes
what the primary-completion date above is the date OFProgression Free Survival (PFS) determined by blinded independent central review (BICR)
measured Until progression or death, assessed up to approximately 4 years
Confirmed overall response rate (ORR) as determined by BICR
measured Until progression or death, assessed up to approximately 3 years
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