Neladalkib (NVL-655)

DRUG2 trials

Sponsors

Nuvalent Inc.

Conditions

Anaplastic Lymphoma Kinase-positiveLocally Advanced Solid TumorMetastatic Solid TumorNon-small Cell Lung Cancer

Phase 1

A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

RecruitingNCT05384626

Nuvalent Inc.Locally Advanced Solid Tumor, Metastatic Solid Tumor

Start: 2022-06-09End: 2028-01-01Target: 840Updated: 2026-05-27

Phase 3

Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

RecruitingNCT06765109

Nuvalent Inc.Anaplastic Lymphoma Kinase-positive, Non-small Cell Lung Cancer

Start: 2025-07-17End: 2029-12-01Target: 450Updated: 2026-08-25

Related Papers

ALKOVE-1: Efficacy and safety of neladalkib in patients with advanced <i>ALK</i> + NSCLC.

Journal of Clinical Oncology2026-05-28

Neladalkib (NVL-655), a highly selective anaplastic lymphoma kinase (ALK) inhibitor, compared to alectinib in first-line treatment of patients with ALK-positive advanced non-small cell lung cancer: The phase 3 ALKAZAR study.

Journal of Clinical Oncology2025-05-284 citations

Abstract B154: Safety and preliminary activity of the selective ALK inhibitor NVL-655 in patients with ALK fusion-positive solid tumors

Molecular Cancer Therapeutics2023-12-014 citations

Abstract 4022: Preclinical intracranial activity of NVL-655 in an alectinib-resistant patient-derived model harboring EML4-ALK fusion with G1202R mutation

Cancer Research2023-04-041 citations