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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 or Other ALK+ Solid Tumors

Conditions
Non Small Cell Lung Cancer
ALK-positive Non-small Cell Lung Cancer (NSCLC)
First Posted Date
2025-02-19
Last Posted Date
2025-11-04
Lead Sponsor
Nuvalent Inc.
Registration Number
NCT06834074
Locations
🇪🇸

Uomi Cancer Center-Clinica Tres Torres, Barcelona, Spain

🇪🇸

Hospital Universitario 12 de Octubre, Madrid, Spain

🇺🇸

University of Colorado Anschutz School of Medicine, Aurora, Colorado, United States

and more 26 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
2025-11-04
Lead Sponsor
Nuvalent Inc.
Registration Number
NCT06797362
Locations
🇺🇸

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

🇨🇦

Cross Cancer Institute, Edmonton, Alberta, Canada

🇮🇹

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

and more 22 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
2025-11-04
Lead Sponsor
Nuvalent Inc.
Target Recruit Count
450
Registration Number
NCT06765109
Locations
🇺🇸

Sylvester Comprehensive Cancer Center Miami, Miami, Florida, United States

🇺🇸

The Ohio State University, Columbus, Ohio, United States

🇰🇷

Samsung Medical Center, Seoul, South Korea

and more 33 locations

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
2025-09-16
Lead Sponsor
Nuvalent Inc.
Target Recruit Count
150
Registration Number
NCT06521554
Locations
🇨🇦

Cross Cancer Institute, Edmonton, Alberta, Canada

🇨🇦

Princess Margaret Cancer Center - University Health Network, Toronto, Ontario, Canada

🇺🇸

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

and more 18 locations

A Study of Neladalkib (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
Drug: Neladalkib (NVL-655)
First Posted Date
2022-05-20
Last Posted Date
2025-10-30
Lead Sponsor
Nuvalent Inc.
Target Recruit Count
840
Registration Number
NCT05384626
Locations
🇯🇵

Cancer Institute Hospital of JFCR, Tokyo, Japan

🇺🇸

University of California Irvine Medical Center, Orange, California, United States

🇺🇸

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

and more 71 locations
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