Neladalkib Compared With Alectinib for Advanced ALK-Positive Lung Cancer
Tests neladalkib against alectinib in adults with advanced ALK-positive lung cancer, not yet treated.
Plain-language title generated from the registry record
Registry title: Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Key facts
- Where
- Córdoba and Rosario, ArgentinaSee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced lung cancer (non-small cell) that has an ALK change and who have not yet had cancer drug treatment for it.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Locally advanced lung cancer that cannot be treated with several methods together, or lung cancer that has spread (metastatic). Measurable disease on scans (1 or more target lesions).
- Earlier treatment
- No earlier whole-body cancer treatment for this lung cancer. Chemotherapy before or after surgery is allowed if it was 12 months before randomization. Earlier ALK TKI drugs, such as alectinib, are not allowed.
- Biomarker or test result
- An ALK rearrangement shown by testing tumor tissue or blood. Tumor tissue from before treatment is needed.
Main reasons for not taking part
- Cancer with a known driver gene change other than ALK
- Brain metastases with worsening symptoms, or needing increasing steroid doses
- Active tuberculosis, or active hepatitis B or C
- Clinically significant heart disease, or QTcF over 470 msec
- Another active cancer needing treatment within 2 years
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT06765109, who can take part
Where in Argentina
- Centro Médico Privado CEMICCórdoba, ArgentinaContact: Luigi Pirelli, MD (principal investigator)Taking people
- Sanatorio AllendeCórdoba, ArgentinaContact: Ignacio Jerez, M.D. (principal investigator)Taking people
- Sanatorio Parque S.A.Rosario, ArgentinaContact: Gaston Martinengo, M.D. (principal investigator)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Nuvalent Inc.
- Trial code
- NCT06765109EU 2024-517553-26-00
- Record updated
- 30 September 2026
- Original 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).Read full original descriptionShow less
A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)
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).
Inclusion: 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: Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization; Major surgery within 4 weeks prior to randomization; Active malignancy requiring therapy within 2 years prior to randomization; Patient's cancer has a known oncogenic driver alteration other than ALK; Known allergy/hypersensitivity to excipients of neladalkib or alectinib; Uncontrolled clinically relevant infection requiring systemic therapy; Known active tuberculosis, or active Hepatitis B or C; Clinically significant cardiovascular disease; Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease; QT corrected for heart rate by Fridericia's formula (QTcF) > 470 msec on repeated assessments.