Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
← catalyst calendarNCT06765109 · readout ≤ 1,229 d
Sponsored by Nuvalent Inc. (industry) · NUVL — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
450estimated
Sites
157
Countries
Argentina, Australia, Austria +26
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 | 2025-07-17 | actual | When the study began enrolling |
| Primary completion | Dec 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-21 | 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
- Anaplastic Lymphoma Kinase-positive
Interventions
- Drug: Neladalkib (NVL-655)
- Drug: Alectinib — also filed as Alecensa
Primary outcome
what the primary-completion date above is the date OFProgression-free survival (PFS) per blinded independent central review (BICR)
measured Up to 5 years after first patient dosed
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