Clinical trial
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
NCT06765109 · Nuvalent Inc., Industry · Recruiting
Key facts
| NCT number | NCT06765109 |
|---|---|
| Title | Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC |
| Official title | A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR) |
| Acronym | ALKAZAR |
| Lead sponsor | Nuvalent Inc., Industry |
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive |
| Intervention type | Drug |
| Interventions | Neladalkib (NVL-655), Alectinib |
| Enrollment | 450 |
| Start date | Jul 17, 2025 |
| Primary completion | Dec 1, 2029 |
| Completion | Dec 1, 2029 |
| First posted | Jan 9, 2025 |
| Last update posted | Jan 12, 2026 |
| Countries | Argentina, Australia, Belgium, Brazil, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Italy and 12 more |
At a glance
- 100–999 Study sites
- No Results posted
- 10–99 FDA inspections linked to this trial
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: