OncoMatch/Clinical Trials/NCT06765109
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Is NCT06765109 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Neladalkib (NVL-655) and Alectinib for non-small cell lung cancer.
Treatment: Neladalkib (NVL-655) · Alectinib — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: ALK rearrangement
Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood
Required: ALK other oncogenic driver alteration
Patient's cancer has a known oncogenic driver alteration other than ALK.
Prior therapy
Cannot have received: ALK inhibitor (alectinib)
prior ALK tyrosine kinase inhibitor [TKI] such as alectinib is not allowed in any setting
Cannot have received: systemic anticancer treatment
Exception: adjuvant/neoadjuvant chemotherapy allowed if 12 months prior to randomization
No prior systemic anticancer treatment for NSCLC (adjuvant/neoadjuvant chemotherapy allowed if 12 months prior to randomization)
Lab requirements
Cardiac function
QTcF > 470 msec on repeated assessments; clinically significant cardiovascular disease
QT corrected for heart rate by Fridericia's formula (QTcF) > 470 msec on repeated assessments; Clinically significant cardiovascular disease
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Palo Verde Hematology Oncology · Glendale, Arizona
- Hoag Hospital Newport Beach · Newport Beach, California
- University of California, Irvine Health · Orange, California
- Rocky Mountain Cancer Centers · Boulder, Colorado
- Sylvester Comprehensive Cancer Center Miami · Miami, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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