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

Recruiting now · Phase 3

Conditions studied: Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive

In brief

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).

Key facts

Study ID

NCT06765109

Run by

Nuvalent Inc.

People needed

450

Starts

2025-07-17

Expected to finish

2029-12-01

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Uncontrolled clinically relevant infection requiring systemic therapy
• Known active tuberculosis, or active Hepatitis B or C
• QT corrected for heart rate by Fridericia's formula (QTcF) > 470 msec on repeated assessments
• Clinically significant cardiovascular disease
• Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease
• Active malignancy requiring therapy within 2 years prior to randomization

Where it is running

• Palo Verde Hematology Oncology — Glendale, Arizona, United States (enrolling)
• University of California, Irvine Health — Orange, California, United States (enrolling)
• Rocky Mountain Cancer Centers — Boulder, Colorado, United States (enrolling)
• Hoag Hospital Newport Beach — Newport Beach, California, United States (enrolling)
• AdventHealth Cancer Institute — Orlando, Florida, United States (enrolling)
• H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States (enrolling)
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Sylvester Comprehensive Cancer Center Miami — Miami, Florida, United States (enrolling)
• Washington University Center for Advanced Medicine — St Louis, Missouri, United States (enrolling)
• NYU Langone's Perlmutter Cancer Center — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Optum Medical Care, PC — Westbury, New York, United States (enrolling)
• Carolinas Medical Center — Charlotte, North Carolina, United States (enrolling)
• Duke Cancer Center — Durham, North Carolina, United States (enrolling)
• University of Cincinnati Cancer Center — Cincinnati, Ohio, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• Alliance Cancer Specialists — Sellersville, Pennsylvania, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
• University of Washington - Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Compass Oncology — Vancouver, Washington, United States (enrolling)
• Sanatorio Parque S.A. — Rosario, Santa Fe Province, Argentina (enrolling)
• Sanatorio Allende — Córdoba, Argentina (enrolling)
• Centro Médico Privado CEMIC — Córdoba, Argentina (enrolling)

Full record on ClinicalTrials.gov

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