ALKOVE-1 (Non-Small Cell Lung Cancer)

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
Professor of Medicine
Protocol Number
IRB: PRO00112155
NCT: NCT05384626
Phase I/II
Enrollment Status