Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

Active:	Yes
Cancer Type:	Lung Cancer	NCT ID:	NCT06765109
Trial Phases:	Phase III	Protocol IDs:	NVL-655-04 (primary) NCI-2025-02510 2024-517553-26
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Nuvalent Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT06765109

Summary

Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate
that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free
survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK)
positive, advanced Non-Small Cell Lung Cancer (NSCLC).

Objectives

Patients will be randomized in a 1:1 ratio (approximately 225 in each arm) to receive
either neladalkib (NVL-655) or alectinib.

Treatment Sites in Georgia

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.