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NCT06765109 · ClinicalTrials.gov registry record · Phase 3
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
A Phase 3 study of Non-Small Cell Lung Cancer and Anaplastic Lymphoma Kinase-positive, sponsored by Nuvalent.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT06765109: Recruiting Phase 3 study of Non-Small Cell Lung Cancer and Anaplastic Lymphoma Kinase-positive, sponsored by Nuvalent.
NCT06765109 is a Phase 3 study of Non-Small Cell Lung Cancer and Anaplastic Lymphoma Kinase-positive that is actively recruiting participants, run by Nuvalent. The registered enrollment target is 450 participants, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06765109, a Phase 3 study of Non-Small Cell Lung Cancer and Anaplastic Lymphoma Kinase-positive, is actively recruiting participants, sponsored by Nuvalent.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Time from randomization to BICR-assessed radiographic disease progression or death
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 |
What NCT06765109 shows while recruiting
NCT06765109 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (31% lower).
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.
NCT06765109 names 20 study sites across 16 states, led by Florida, New York, Ohio.
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.
What interventions are being tested in trial NCT06765109?
The interventions under investigation include: Alectinib (DRUG), Neladalkib (NVL-655) (DRUG).
Who is sponsoring clinical trial NCT06765109?
This trial is sponsored by Nuvalent, which has 4 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT06765109's enrollment target sits among peer trials
450 89th of 454 higher than 366 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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