Nuvalent Alkazar-NVL-655 vs Alectinib 1st line treatment for ALK+ Non-Small Cell Lung cancer

Purpose of this Study

We are doing this study to find the most effective, safe dose of an experimental drug called NVL-655 (the study drug). We want to know how well the study drug works compared to alectinib, which is a standard treatment for NSCLC.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with locally advanced or metastatic NSCLC
  • Have a documented ALK rearrangement in tissue or blood
  • Have not received prior systemic anticancer treatment for NSCLC
For more information, contact the study team at annemarie.peters@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will get a random assignment (by chance) to 1 of 2 study groups, Arm A or Arm B.
  • If you are in Arm A, you will get the study drug. The study drug comes as a tablet, and you will take it by mouth once per day.
  • If you are in Arm B, you will get alectinib. Alectinib is a capsule. You will take it by mouth twice a day.
During the study visits the following procedures may occur: physical examinations, eye examinations, vital signs recording, blood and urine samples collected, electrocardiograms, imaging (CT or MRI) scans, tumor samples, and questionnaires. The duration of your participation in the study will depend on how long you receive study drug, the overall duration of the study, and how long you are willing to participate. If the research study is stopped prematurely for any reason, your study doctor will tell you and arrange your continuing care.

Locations

Duke University Hospital
Duke Raleigh Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full 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)

Principal Investigator

Thomas
Stinchcombe

Protocol Number

PRO00117309

NCT ID

NCT06765109

Phase

III

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov