Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Public ClinicalTrials.gov record NCT06765109. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Study identification
- NCT ID
- NCT06765109
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Nuvalent Inc.
- Industry
- Enrollment
- 450 participants
Conditions and interventions
Interventions
- Alectinib Drug
- Neladalkib (NVL-655) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 16, 2025
- Primary completion
- Nov 30, 2029
- Completion
- Nov 30, 2029
- Last update posted
- May 4, 2026
2025 – 2029
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Palo Verde Hematology Oncology | Glendale | Arizona | 85304 | Recruiting |
| Hoag Hospital Newport Beach | Newport Beach | California | 92663 | Recruiting |
| University of California, Irvine Health | Orange | California | 92868 | Recruiting |
| Rocky Mountain Cancer Centers | Boulder | Colorado | 80218 | Recruiting |
| Sylvester Comprehensive Cancer Center Miami | Miami | Florida | 33136 | Recruiting |
| AdventHealth Cancer Institute | Orlando | Florida | 32804 | Recruiting |
| H Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | Recruiting |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | Withdrawn |
| Washington University Center for Advanced Medicine | St Louis | Missouri | 63110 | Recruiting |
| NYU Langone's Perlmutter Cancer Center | New York | New York | 10016 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| Optum Medical Care, PC | Westbury | New York | 11590 | Recruiting |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | Recruiting |
| Duke Cancer Center | Durham | North Carolina | 27710 | Recruiting |
| University of Cincinnati Cancer Center | Cincinnati | Ohio | 45267 | Recruiting |
| The Ohio State University | Columbus | Ohio | 43210 | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | Recruiting |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | Recruiting |
| University of Washington - Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 128 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06765109, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 4, 2026 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06765109 live on ClinicalTrials.gov.