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Nuvalent

Nuvalent logo
🇺🇸United States
Ownership
Public
Established
2017-01-01
Employees
92
Market Cap
$5.4B
Website
http://www.nuvalent.com
Introduction

Nuvalent, Inc. is a clinical stage biopharmaceutical company, which focuses on creating precisely targeted therapies for patients with cancer. Its pipeline includes ROS1 NSCLC, ALK NSCLC and HER2 NSCLC. The company was founded by Matthew D. Shair in January 2017 and is headquartered in Cambridge, MA.

Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC

Conditions
Non Small Cell Lung Cancer
ALK-positive Non-small Cell Lung Cancer (NSCLC)
First Posted Date
2025-02-19
Last Posted Date
2025-05-08
Lead Sponsor
Nuvalent Inc.
Registration Number
NCT06834074
Locations
🇨🇭

Kantonsspital Luzern, Lucerne, Switzerland

🇫🇷

GCS IUCT Oncopole, Toulouse, Occitanie, France

🇫🇷

Institut Gustave Roussy, Villejuif, Île-de-France, France

and more 9 locations

Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC (NVL-520-EAP)

Conditions
Non Small Cell Lung Cancer
ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
First Posted Date
2025-01-28
Last Posted Date
2025-05-08
Lead Sponsor
Nuvalent Inc.
Registration Number
NCT06797362
Locations
🇫🇷

Centre Leon Berard, Lyon, Auvergne-Rhône-Alpes, France

🇳🇱

University Medical Center Groningen, Groningen, Netherlands

🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

and more 6 locations

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

Phase 3
Recruiting
Conditions
Non-small Cell Lung Cancer
Anaplastic Lymphoma Kinase-positive
Interventions
Drug: Neladalkib (NVL-655)
First Posted Date
2025-01-09
Last Posted Date
2025-03-12
Lead Sponsor
Nuvalent Inc.
Target Recruit Count
450
Registration Number
NCT06765109
Locations
🇺🇸

Washington University Center for Advanced Medicine, Saint Louis, Missouri, United States

🇺🇸

Clinical Research Alliance Inc., New Hyde Park, New York, United States

A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)

Phase 1
Recruiting
Conditions
Locally Advanced Solid Tumor
Metastatic Solid Tumor
Interventions
First Posted Date
2024-07-26
Last Posted Date
2025-05-11
Lead Sponsor
Nuvalent Inc.
Target Recruit Count
120
Registration Number
NCT06521554
Locations
🇺🇸

City of Hope - Lennar, Irvine, California, United States

🇺🇸

OSU Brain and Spine Hospital, Columbus, Ohio, United States

🇦🇺

North Shore Health Hub, Saint Leonards, New South Wales, Australia

and more 13 locations

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

Phase 1
Recruiting
Conditions
Locally Advanced Solid Tumor
Metastatic Solid Tumor
Interventions
First Posted Date
2022-05-20
Last Posted Date
2024-12-13
Lead Sponsor
Nuvalent Inc.
Target Recruit Count
470
Registration Number
NCT05384626
Locations
🇩🇪

Universitatsklinikum Koln - University Hospital Cologne, Cologne, Germany

🇩🇪

Universkitatsklinikum Heidelberg - University Hospital Heidelberg, Heidelberg, Germany

🇯🇵

Okayama University Hospital, Okayama, Japan

and more 67 locations

A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

Phase 1
Recruiting
Conditions
Metastatic Solid Tumor
Locally Advanced Solid Tumor
Interventions
First Posted Date
2021-11-12
Last Posted Date
2025-03-07
Lead Sponsor
Nuvalent Inc.
Target Recruit Count
359
Registration Number
NCT05118789
Locations
🇺🇸

UCI Medical Center, Orange, California, United States

🇺🇸

Stanford Medicine, Palo Alto, California, United States

🇺🇸

UC Davis Comprehensive Cancer Center, Sacramento, California, United States

and more 60 locations
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