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.
- 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?
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.
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 ACCRUAL