A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
← catalyst calendarNCT05118789 · readout in 499 d
Sponsored by Nuvalent Inc. (industry) · NUVL — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
359estimated
Sites
63
Countries
Australia, Belgium, Canada +11
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 | 2022-01-04 | actual | When the study began enrolling |
| Primary completion | 2027-12-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2021-11-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Locally Advanced Solid Tumor
- Metastatic Solid Tumor
Intervention
- Drug: Zidesamtinib (NVL-520)
Primary outcomes
what the primary-completion date above is the date OFMaximum Tolerated Dose (MTD) (Phase 1)
measured Within 28 days of last patient dosed during dose escalation
Recommended Phase 2 Dose (RP2D)
measured Within 28 days of last patient dosed during dose escalation.
Objective Response Rate (ORR) (Phase 2)
measured 2-3 years after first patient dosed.
Permalink · NUVL's whole pipeline · Catalyst calendar · Every registered study · What changed