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:<ul>
<li>Are diagnosed with advanced NSCLC</li>
<li>Are positive for the ALK gene</li></ul>
For more information about who can be in this study, please contact the study team at <a href= "mailto: annmarie.peters@dm.duke.edu">annmarie.peters@dm.duke.edu.</a>

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:<ul>
<li>Have blood draws</li>
<li>Visit the clinic for various tests to see if you're eligible for the dosing period</li></ul>
If you're eligible for the dosing period, you will:
<li>Have blood draws</li>
<li>Have imaging scans (CT and MRI)</li>
<li>Receive the study drug</li></ul>
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