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

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

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06765109
Protocol IDs
NVL-655-04 (primary)
NCI-2025-02510
2024-517553-26
Study Sponsor
Nuvalent Inc.

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.

Eligibility

  1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)
  2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood
  3. No prior systemic anticancer treatment for NSCLC (adjuvant/neoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor [TKI] such as alectinib is not allowed in any setting)
  4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
  5. Pretreatment tumor tissue

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.