ALKOVE-1 (Non-Small Cell Lung Cancer)

Purpose of this Study

We are doing this study to find out if a new experimental drug called NVL-655 (the study drug) is a beneficial option for people with NSCLC.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with advanced NSCLC
  • Are positive for the ALK gene
For more information about who can be in this study, please contact the study team at annmarie.peters@dm.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

This study has 2 parts, a screening period and a study dosing period. If you join this study, during the screening period you will:
  • Have blood draws
  • Visit the clinic for various tests to see if you're eligible for the dosing period
If you're eligible for the dosing period, you will:
  • Have blood draws
  • Have imaging scans (CT and MRI)
  • Receive the study drug
    • The study drug is given as an infusion into a vein (IV) every 3 weeks. Different doses of the study drug are being tested in this study. The dose of NVL-655 you receive will depend on when you enter the study. You will continue to receive the study drug for as long as you and the study doctor believe that you are receiving a benefit from it.

    Locations

    Duke University Hospital

    Visit Timing

    Weekdays

    Compensation

    No

    Spanish Materials Available

    No

    Study Details

    Full Title

    Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1). NVL-655-01.

    Principal Investigator

    Thomas
    Stinchcombe

    Protocol Number

    PRO00112155

    NCT ID

    NCT05384626

    Phase

    I/II

    Enrollment Status

    Open to Enrollment
    ClinicalTrials.gov