NCT06765109 · Nuvalent Inc.
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
(ALKAZAR)
What this study is about
conducted at multiple hospitals, randomly assigned, controlled, where both patients and doctors know the treatment given, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging time without the disease getting worse (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).
View original scientific description
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).
Interventions
DRUG
Neladalkib (NVL-655)
Oral tablet of Neladalkib (NVL-655)
DRUG
Alectinib
Oral capsule of alectinib
Primary outcome measures
Progression-free survival (PFS) per blinded independent central review (BICR)
Time frame: Up to 5 years after first patient dosed
Time from randomization to BICR-assessed radiographic disease progression or death
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Patient's cancer has a known oncogenic driver alteration other than ALK. 2. Known allergy/hypersensitivity to excipients of neladalkib or alectinib. 3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization 4. Major surgery within 4 weeks prior to randomization 5. Uncontrolled clinically relevant infecti
Where
- Glendale, Arizona
- Newport Beach, California
- Orange, California
- Boulder, Colorado
- Miami, Florida
- Orlando, Florida
- Tampa, Florida
- Atlanta, Georgia
- Boston, Massachusetts
- Detroit, Michigan
- St Louis, Missouri
- New York, New York
And 9 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations