Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC (NCT06765109) | Clinical Trial Compass
RecruitingPhase 3
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
United States450 participantsStarted 2025-07-17
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Patient's cancer has a known oncogenic driver alteration other than ALK.
✕. Known allergy/hypersensitivity to excipients of neladalkib or alectinib.
✕. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization
✕. Major surgery within 4 weeks prior to randomization