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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 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 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (32% lower). The trial reports 20 study locations across 16 states.

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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).

Conditions Studied

Non-Small Cell Lung Cancer Anaplastic Lymphoma Kinase-positive

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

FieldValue
Enrollment Target 450 participants
Start Date 2025-07-17
Est. Completion 2029-12
Phase Phase 3

Sponsor

Nuvalent

4 total trials

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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, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (32% lower). The listed sponsor is Nuvalent, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.