ALKOVE-1 (Non-Small Cell Lung Cancer) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Advanced Non-Small Cell Lung Cancer (NSCLC)

Who Can Participate in the Study?

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

Age Group

What is Involved?

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.

    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
    Medical Oncologist
    Protocol Number
    IRB: PRO00112155
    NCT: NCT05384626
    Phase I/II
    Enrollment Status
    Open for Enrollment