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
- Aarhus N, Herlev, and Odense C, DenmarkSee the 3 sites
- Phase
- Phase 3
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 Denmark
- Region MidtjyllandAarhus N, DenmarkTaking people
- Region HovedstadenHerlev, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking 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?
Trial 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.