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NVL-655

DRUG3 trials

Sponsors

Nuvalent Inc.

Conditions

ALK-positive Non-small Cell Lung Cancer (NSCLC)Advanced ALK-positive non-small cell lung cancer (NSCLC)Advanced Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors with ALK rearrangement or activating ALK mutationNon Small Cell Lung Cancer

Phase 1

A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
RecruitingCTIS2024-514266-39-00
Nuvalent Inc.Advanced Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors with ALK rearrangement or activating ALK mutation
Start: 2022-11-03Target: 350Updated: 2025-11-17

Phase 3

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)
RecruitingCTIS2024-517553-26-00
Nuvalent Inc.Advanced ALK-positive non-small cell lung cancer (NSCLC)
Start: 2025-11-12Target: 291Updated: 2026-01-06

Unknown Phase

Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
NCT06834074
Nuvalent Inc.ALK-positive Non-small Cell Lung Cancer (NSCLC), Non Small Cell Lung Cancer
Updated: 2026-03-09