Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
18 Years and older, Male and Female
NVL-655-04 (primary)
NCI-2025-02510
2024-517553-26
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
- Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)
- Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood
- 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)
- Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
- Pretreatment tumor tissue
Treatment Sites in Georgia
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