Last updated 25 days ago
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
450 patients around the world
Available in Argentina, United States
Patients will be randomized in a 1:1 ratio (approximately 225 in each arm) to receive
either neladalkib (NVL-655) or alectinib.
Nuvalent Inc.
13Research sites
450Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Sanatorio Allende (Nueva Córdoba)
Recruiting
Sanatorio Parque - Rosario
Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Recruiting
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
Hospital De Base de São José do Rio Preto - CIP São José
Recruiting
Hospital Amaral Carvalho
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Santa Casa de Misericórdia de Belo Horizonte
Recruiting
AC Camargo Cancer Center
Recruiting
StudyALKAZAR
SponsorNuvalent Inc.
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06765109
