Core Viewpoint - Nuvalent, Inc. has initiated the ALKAZAR Phase 3 trial to evaluate neladalkib for TKI-naïve patients with advanced ALK-positive non-small cell lung cancer (NSCLC), comparing it to the standard of care, ALECENSA® [1][2] Group 1: Clinical Trial Details - The ALKAZAR trial aims to enroll approximately 450 TKI-naïve patients, with a 1:1 randomization to receive either neladalkib or alectinib [2] - The primary endpoint of the trial is progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR), with several secondary endpoints including overall survival and intracranial response metrics [2][3] Group 2: Neladalkib Profile - Neladalkib is designed to address treatment limitations of existing ALK inhibitors, particularly for patients with brain metastases and resistance mutations [5] - The drug has received breakthrough therapy designation for patients with locally advanced or metastatic ALK-positive NSCLC previously treated with two or more ALK tyrosine kinase inhibitors [5] Group 3: Company Overview - Nuvalent, Inc. focuses on developing targeted therapies for cancer, leveraging expertise in chemistry and structure-based drug design [6][7] - The company is advancing a pipeline that includes investigational candidates for ROS1-positive, ALK-positive, and HER2-altered NSCLC, along with multiple discovery-stage research programs [7]