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Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
NCT06765109 · View on ClinicalTrials.gov ↗
Study Summary
Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).
Conditions Studied
Interventions
- DRUG Alectinib
- DRUG Neladalkib (NVL-655)
Study Locations (20)
Florida
- Sylvester Comprehensive Cancer Center Miami — Miami
- AdventHealth Cancer Institute — Orlando
- H Lee Moffitt Cancer Center and Research Institute — Tampa
New York
- Memorial Sloan Kettering Cancer Center — New York
- Optum Medical Care, PC — Westbury
Ohio
- University of Cincinnati Cancer Center — Cincinnati
- The Ohio State University — Columbus
Arizona
- Palo Verde Hematology Oncology — Glendale
California
- University of California, Irvine Health — Orange
Colorado
- Rocky Mountain Cancer Centers — Denver
Georgia
- Winship Cancer Institute of Emory University — Atlanta
Massachusetts
- Dana-Farber Cancer Institute — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2025-07-17 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06765109
The ClinicalTrials.gov registry entry for NCT06765109 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nuvalent, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions — of which Alectinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06765109 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Florida, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06765109 about?
NCT06765109 is a clinical study titled "Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC". Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NS...
What is the current status of trial NCT06765109?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2025-07-17. Estimated completion is 2029-12.
What conditions does trial NCT06765109 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06765109?
The interventions under investigation include: Alectinib (DRUG), Neladalkib (NVL-655) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06765109?
This trial is sponsored by Nuvalent, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06765109 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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