New ALK inhibitor NVL-655 enters trials for Hard-to-Treat cancers

NCT ID NCT05384626

Recruiting now Disease control Sponsor: Nuvalent Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called neladalkib (NVL-655) in people with advanced ALK-positive non-small cell lung cancer and other solid tumors. The trial has two parts: Phase 1 finds the safest dose, and Phase 2 checks how well it shrinks tumors. Up to 840 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Neladalkib (NVL-655)
What this could lead to: If successful, this could provide a new treatment option for people with ALK-positive cancers that have stopped responding to other therapies.
What could go wrong: This is an early-phase trial, so the drug may not work as hoped or could cause unexpected side effects. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

LOCALLY ADVANCED SOLID TUMOR METASTATIC SOLID TUMOR

Contacts and locations

Locations

Azienda Ospedaliera Universitaria Ospedali Riuniti Umberto
RECRUITING

Ancona, 60126, Italy
BC Cancer Center
RECRUITING

Vancouver, British Columbia, VZ 4E6, Canada
Cancer Institute Hospital of JFCR
RECRUITING

Tokyo, 1358550, Japan
Centre Leon Berard
RECRUITING

Lyon, 69373, France
Chu De Nantes
RECRUITING

Nantes, 44093, France
Chung-Shan Medical University Hospital
RECRUITING

Taichung, 402306, Taiwan
Complejo Hospitalario Universitario de A Coruna
RECRUITING

A Coruña, 15006, Spain
Cross Cancer Institute
RECRUITING

Edmonton, Alberta, T6G 1Z2, Canada
Dana Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Duke University Medical Center
RECRUITING

Durham, North Carolina, 27705, United States
Edinburgh Cancer Centre
RECRUITING

Edinburgh, EH4 2XU, United Kingdom
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING

Milan, 20133, Italy
Fred Hutchinson Cancer Center
RECRUITING

Seattle, Washington, 98109, United States
Georgetown University Medical Center
RECRUITING

Washington D.C., District of Columbia, 20007, United States
Henry Ford Cancer Institute
RECRUITING

Detroit, Michigan, 48202, United States
Hospital General Universitario Gregorio Maranon
RECRUITING

Madrid, 28009, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
IRCCS Istituto Tumori "G. Paolo II"
RECRUITING

Bari, 70124, Italy
Institut Claudius Regaud
RECRUITING

Toulouse, 31059, France
Institute Gustave Roussy
RECRUITING

Villejuif, 94805, France
Instituto Europeo di Oncologia
RECRUITING

Milan, 20141, Italy
Instituto Oncologico Veneto
RECRUITING

Padova, 35128, Italy
Istituto Oncologico Svizzera Italiana
RECRUITING

Bellinzona, 6500, Switzerland
John Hopkins University
RECRUITING

Baltimore, Maryland, 21224, United States
Kanagawa Cancer Center
RECRUITING

Kanagawa, 2418515, Japan
Kindai University Hospital
RECRUITING

Osaka, 5898511, Japan
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITING

New York, New York, 10016, United States
LungenClinic Grosshansdorf GmbH
RECRUITING

Großhansdorf, 22927, Germany
Luzerner Kantonsspital
RECRUITING

Lucerne, 6000, Switzerland
MD Anderson Cancer Center
ACTIVE_NOT_RECRUITING

Houston, Texas, 77030, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
National Cancer Center
RECRUITING

Goyang-si, Gyeonggi-do, 10408, South Korea
National Cancer Center Hospital
RECRUITING

Tokyo, 1040051, Japan
National Cancer Centre Singapore
RECRUITING

Singapore, Singapore, 168583, Singapore
National Cheng Kung University Hospital
RECRUITING

Tainan, 70403, Taiwan
National Taiwan University Hospital
RECRUITING

Taipei, 10002, Taiwan
National University Hospital
RECRUITING

Singapore, Singapore, 119074, Singapore
OSU Brain & Spine Hospital
RECRUITING

Columbus, Ohio, 43210, United States
Okayama University Hospital
RECRUITING

Okayama, 7008558, Japan
Ospedale Santa Maria delle Croci
RECRUITING

Ravenna, 48100, Italy
Peter MacCallum Cancer Centre
RECRUITING

Melbourne, Victoria, 3000, Australia
Princess Alexandra Hospital
RECRUITING

Woolloongabba, Queensland, 4102, Australia
Princess Margaret Cancer Centre
RECRUITING

Toronto, Ontario, M5G 0A3, Canada
Regina Elena Institute for Cancer Research
RECRUITING

Rome, 00144, Italy
Royal Marsden Hospital
RECRUITING

Sutton, Surrey, SM2 5PT, United Kingdom
Royal North Shore Hospital
RECRUITING

Sydney, New South Wales, 2065, Australia
Samsung Medical Center
RECRUITING

Seoul, 06351, South Korea
Sarah Cannon
RECRUITING

Nashville, Tennessee, 37203, United States
Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
RECRUITING

Seoul, 03722, South Korea
Shizuoka Cancer Center
RECRUITING

Shizuoka, 4118777, Japan
Stanford Cancer Institute
RECRUITING

Stanford, California, 94305, United States
The Christie NHS Foundation Trust
RECRUITING

Manchester, M20 4BX, United Kingdom
The Netherlands Cancer Institute
RECRUITING

Amsterdam, 1066 CX, Netherlands
The Ottawa Hospital Cancer Center
RECRUITING

Ottawa, Ontario, K1H 8L6, Canada
The Royal Marsden - Chelsea
RECRUITING

London, SM2 5PT, United Kingdom
UOMI Cancer Center
RECRUITING

Barcelona, 08017, Spain
Universitair Ziekenhuis Antwerpen (UZA)
RECRUITING

Antwerp, 2650, Belgium
Universitaire Ziekenhuizen Leuven Campus Gastthuisberg
RECRUITING

Leuven, 3000, Belgium
Universitatsklinikum Koln - University Hospital Cologne
RECRUITING

Cologne, 50937, Germany
University Medical Center Groningen (UMCG)
RECRUITING

Groningen, 9713 GZ, Netherlands
University of California Irvine Medical Center
RECRUITING

Orange, California, 92868, United States
University of California, Davis Comprehensive Cancer Center
RECRUITING

Sacramento, California, 95817, United States
University of Chicago Medical Center
RECRUITING

Chicago, Illinois, 60637, United States
University of Colorado Cancer Center
RECRUITING

Aurora, Colorado, 80045, United States
University of Miami; Sylvester Cancer Center
RECRUITING

Miami, Florida, 33136, United States
University of Pennsylvania, Abramson Cancer Center
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Universitätsklinikum Frankfurt
RECRUITING

Frankfurt, 60590, Germany
Universkitatsklinikum Heidelberg - University Hospital Heidelberg
RECRUITING

Heidelberg, 69126, Germany
Vall d'Hebron
RECRUITING

Barcelona, 08035, Spain
Wakayama Medical University Hospital
RECRUITING

Wakayama, 6418510, Japan
Washington University School of Medicine Siteman Cancer Center
RECRUITING

St Louis, Missouri, 63310, United States
Winship Cancer Institute, Emory University
RECRUITING

Atlanta, Georgia, 30322, United States

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