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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.

Clinical Trials

7

Active:0
Completed:0

Trial Phases

2 Phases

Phase 1:3
Phase 3:1

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (5 trials with phase data)• Click on a phase to view related trials

Phase 1
3 (60.0%)
phase_1_2
1 (20.0%)
Phase 3
1 (20.0%)

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
2025-06-06
Lead Sponsor
Nuvalent Inc.
Registration Number
NCT06834074
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇬🇧

The Royal Marsden Hospital, London, UK, United Kingdom

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 11 locations

Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors

Conditions
Non Small Cell Lung Cancer
ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
First Posted Date
2025-01-28
Last Posted Date
2025-06-06
Lead Sponsor
Nuvalent Inc.
Registration Number
NCT06797362
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇳🇱

Netherlands Cancer Institute: NKI, Amsterdam, Netherlands

🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

and more 8 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
2025-06-17
Lead Sponsor
Nuvalent Inc.
Target Recruit Count
120
Registration Number
NCT06521554
Locations
🇺🇸

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

🇺🇸

University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States

🇺🇸

Stanford Cancer Institute, Stanford, California, United States

and more 14 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
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