Last updated 6 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.

1Research sites

450Patients around the world

This study is for people with

Lung cancer

Non-small cell lung carcinoma

From 18 Years

All Gender

: 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.

Sanatorio Parque - Rosario

Recruiting

Boulevard Oroño 860, Rosario, Santa Fe

StudyALKAZAR

SponsorNuvalent Inc.

Study typeInterventional

Conditions

Non-small cell lung carcinoma

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06765109