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)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06765109Tipo: INTERVENTIONALInicio: 17 de jul de 2025Fin estimado: 1 de dic de 2029

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Resumen

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).

Descripción detallada

Patients will be randomized in a 1:1 ratio (approximately 225 in each arm) to receive either neladalkib (NVL-655) or alectinib.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Neladalkib (NVL-655)

Oral tablet of Neladalkib (NVL-655)

drug

Alectinib

Oral capsule of alectinib

Ubicaciones

Sanatorio Parque S.A.

Rosario, Santa Fe Province, Argentina

Gaston Martinengo, M.D.

RECRUITING

Sanatorio Allende

Córdoba, Argentina

Ignacio Jerez, M.D.

RECRUITING

Patrocinadores

PrincipalNuvalent Inc.

Contactos

Nuvalent Clinical Trials

CONTACT

clinicaltrials@nuvalent.com 857-357-7000

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