New ALK inhibitor NVL-655 takes on standard therapy in lung cancer trial

NCT ID NCT06765109

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

First seen Jun 25, 2026 · Last updated Jul 22, 2026 · Updated 5 times

Summary

This phase 3 study compares a new drug, NVL-655, to the standard treatment alectinib in people with advanced ALK-positive non-small cell lung cancer who have not had prior therapy. About 450 participants will be randomly assigned to receive either NVL-655 or alectinib. The main goal is to see if NVL-655 can delay cancer growth or death better than alectinib.

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) and alectinib
What this could lead to: If NVL-655 works better than alectinib, it could become a new first-choice treatment for ALK-positive lung cancer, potentially keeping the cancer under control for longer.
What could go wrong: This is a large phase 3 trial, but NVL-655 is still experimental. It may not prove superior to alectinib, and side effects could be similar or worse. Results are not guaranteed.

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.

ALK-positive anaplastic large cell lymphoma lung disorder lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

ANAPLASTIC LYMPHOMA KINASE-POSITIVE NON-SMALL CELL LUNG CANCER

Contacts and locations

Locations

A.C.Camargo Cancer Center
RECRUITING

São Paulo, 01509-010, Brazil
APHP - Hôpital Tenon
RECRUITING

Paris, 75020, France
ASL Taranto Ospedale S. G. Moscati
RECRUITING

Statte, 74010, Italy
AUSL Della Romagna - Ospedale Santa Maria delle Croci
RECRUITING

Ravenna, 48121, Italy
Aarhus Universitetshospital
RECRUITING

Aarhus, 8200, Denmark
AdventHealth Cancer Institute
RECRUITING

Orlando, Florida, 32804, United States
Aichi Cancer Center
RECRUITING

Chikusa, 464-8681, Japan
Alliance Cancer Specialists
RECRUITING

Sellersville, Pennsylvania, 18960, United States
Antwerp University Hospital
RECRUITING

Edegem, 2650, Belgium
Athens Medical Center
RECRUITING

Marousi, 151 25, Greece
Austin Health
RECRUITING

Heidelberg, Victoria, 3084, Australia
Azienda Ospedaliero Universitaria Pisana
RECRUITING

Pisa, 56126, Italy
Azienda Ospedaliero Universitaria delle Marche
RECRUITING

Ancona, 60126, Italy
Bacs-Kiskun Varmegyei Oktatokorhaz
RECRUITING

Kecskemét, 6000, Hungary
Barbara Ann Karmanos Cancer Institute
WITHDRAWN

Detroit, Michigan, 48201, United States
Beacon International Specialist Centre
RECRUITING

Petaling Jaya, Selangor, 46050, Malaysia
CUF Porto Hospital
RECRUITING

Porto, 4100-180, Portugal
Cambridge University Hospitals NHS Trust, Addenbrooke's Hospital
RECRUITING

Cambridge, NG5 1PB, United Kingdom
Carolinas Medical Center
RECRUITING

Charlotte, North Carolina, 28203, United States
Center for Lung Cancer, National Cancer Center
RECRUITING

Goyang-si, 10408, South Korea
Centre Francois Baclesse
RECRUITING

Caen, 14076, France
Centre Hospitalier Universitaire (CHU) Nantes Hopital Nord Laennec
RECRUITING

Nantes, 44093, France
Centre Hospitalier Universitaire (CHU) de Bordeaux
RECRUITING

Pessac, 33604, France
Centre Hospitalier Universitaire d' Angers
RECRUITING

Angers, 49000, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
RECRUITING

Toulouse, 31059, France
Centre Leon Berard
RECRUITING

Lyon, 69373, France
Centro Médico Privado CEMIC
RECRUITING

Córdoba, X5008, Argentina
Centro Oncológico Personalizado
RECRUITING

Mexico City, 06760, Mexico
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
RECRUITING

Morelia, 58260, Mexico
Centro de Investigaciones Clinicas UC CICUC
RECRUITING

Santiago, 8320000, Chile
Centro de Oncologia de Precision de la Universidad Mayor
RECRUITING

Santiago, 5750, Chile
Chung Shan Medical University
RECRUITING

Taichung, 40201, Taiwan
Chungbuk National University Hospital
RECRUITING

Cheongju-si, 28644, South Korea
Cliniques Universitaires Saint-Luc
RECRUITING

Brussels, 1200, Belgium
Compass Oncology
RECRUITING

Vancouver, Washington, 98684, United States
Complejo Hospitalario Universitario a Coruña
RECRUITING

A Coruña, 15006, Spain
Dana-Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
RECRUITING

Debrecen, 4032, Hungary
Duke Cancer Center
RECRUITING

Durham, North Carolina, 27710, United States
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING

Milan, 20133, Italy
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING

Monza, 20900, Italy
Fundacao Champalimaud
RECRUITING

Lisbon, 1400-038, Portugal
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base
RECRUITING

São José do Rio Preto, 15090, Brazil
Fundacion Arturo Lopez Perez FALP
RECRUITING

Providencia, 7500000, Chile
Fundação Pio XII
RECRUITING

Barretos, 14784, Brazil
GENESIS General Clinic
RECRUITING

Thessaloniki, 555 35, Greece
Gachon University Gil Medical Center
RECRUITING

Incheon, 21565, South Korea
Guy's Cancer Centre NHS Foundation Trust
RECRUITING

London, SE1 9RT, United Kingdom
H Lee Moffitt Cancer Center and Research Institute
RECRUITING

Tampa, Florida, 33612, United States
HRH Princess Maha Chakri Sirindhorn Medical Center
RECRUITING

Ongkharak, 26120, Thailand
Health Pharma Professional Research S.A de C.V.
RECRUITING

Mexico City, 03100, Mexico
Helios Klinikum Emil von Behring GmbH
RECRUITING

Berlin, 14165, Germany
Henry Dunant Hospital Center
RECRUITING

Athens, 115 26, Greece
Herlev and Gentofte Hospital
RECRUITING

Herlev, 02730, Denmark
Hoag Hospital Newport Beach
RECRUITING

Newport Beach, California, 92663, United States
Hospital Amaral Carvalho
RECRUITING

São Paulo, 17210-080, Brazil
Hospital General Universitario Gregorio Marañon
RECRUITING

Madrid, 28007, Spain
Hospital Kuala Lumpur
RECRUITING

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia
Hospital Nord
RECRUITING

Marseille, 13015, France
Hospital Pulau Pinang
RECRUITING

George Town, Pulau Pinang, 10450, Malaysia
Hospital Regional Universitario de Malaga
RECRUITING

Málaga, 29010, Spain
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul
RECRUITING

Porto Alegre, 90610, Brazil
Hospital Umum Sarawak
RECRUITING

Kuching, 93586, Malaysia
Hospital Universitari de Girona Dr Josep Trueta
RECRUITING

Girona, 17007, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital Universitario Dr. Jose Eleuterio González
RECRUITING

Monterrey, 64660, Mexico
Hospital Universitario Ramon y Cajal
RECRUITING

Madrid, 28034, Spain
Hospital Universitario Virgen Macarena
RECRUITING

Seville, 41009, Spain
Hospital Universitario Virgen del Rocio
RECRUITING

Seville, 41013, Spain
Hospital de Cascais
RECRUITING

Alcabideche, 2755-009, Portugal
ICO Badalona H.U. Germans Trias i Pujol
RECRUITING

Badalona, 08916, Spain
IRCCS Istituto Tumori Giovanni Paolo II
RECRUITING

Bari, 70124, Italy
Institut Bergonie
RECRUITING

Bordeaux, 33000, France
Institut Kanser Negara
RECRUITING

Putrajaya, Putrajaya, 62250, Malaysia
Institut Regional du Cancer de Montpellier
RECRUITING

Montpellier, 34298, France
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
RECRUITING

Porto, 4200-072, Portugal
Instituto do Cancer do Estado de São Paulo ICESP
RECRUITING

São Paulo, 01246-000, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
RECRUITING

Porto Alegre, 90035, Brazil
Istituti Fisioterapici Ospitalieri - IRCCS Istituto Nazionale Tumori Regina Elena
RECRUITING

Roma, 00144, Italy
Istituto Clinico Humanitas
RECRUITING

Milan, 20089, Italy
Istituto Europeo di Oncologia
RECRUITING

Milan, 20141, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
RECRUITING

Meldola, 47014, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
RECRUITING

Torino, 10060, Italy
Kanagawa Cancer Center
RECRUITING

Yokohama, 241-8515, Japan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING

Kaohsiung City, 80756, Taiwan
Kindai University Hospital
RECRUITING

Sakai, 590-0197, Japan
Klinikum Esslingen GmbH
RECRUITING

Esslingen am Neckar, 73730, Germany
Kyushu University Hospital
RECRUITING

Fukuoka, Fukuoka, 812-8582, Japan
LungenClinic Grosshansdorf GmBH
RECRUITING

Großhansdorf, D-22927, Germany
Lungenfachklinik Immenhausen
RECRUITING

Immenhausen, 34376, Germany
Luzerner Kantonsspital
RECRUITING

Lucerne, 6004, Switzerland
MVZ Onkologie Velbert
RECRUITING

Velbert, 42551, Germany
Maharaj Nakorn Chiang Mai Hospital
RECRUITING

Chiang Mai, 50200, Thailand
Maidstone Hospital
RECRUITING

Maidstone, ME16 9QQ, United Kingdom
Matrai Gyogyintezet
RECRUITING

Gyöngyös, 7151, Hungary
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
NYU Langone's Perlmutter Cancer Center
RECRUITING

New York, New York, 10016, United States
National Cancer Center Hospital
RECRUITING

Tokyo, 1040045, Japan
National Cancer Centre Singapore
RECRUITING

Singapore, 168583, Singapore
National Cheng Kung University Hospital
RECRUITING

Tainan, 70403, Taiwan
National Taiwan University Hospital
RECRUITING

Taipei, Taiwan
Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
RECRUITING

Amsterdam, 1066 CX, Netherlands
Nemocnice AGEL Nový Jičín a.s.
RECRUITING

Nový Jičín, 74101, Czechia
Nottingham City Hospital
RECRUITING

Nottingham, NG5 1PB, United Kingdom
Okayama University Hospital
RECRUITING

Okayama, 700-8558, Japan
Oncologia Integral Satelite S. A. de C. V.
RECRUITING

Naucalpan, 53100, Mexico
Oncovida - Santiago
RECRUITING

Santiago, 8320000, Chile
One Day Med
RECRUITING

Szczecin, 70-419, Poland
Optum Medical Care, PC
RECRUITING

Westbury, New York, 11590, United States
Osaka International Cancer Institute
RECRUITING

Osaka, 541-8567, Japan
Palo Verde Hematology Oncology
RECRUITING

Glendale, Arizona, 85304, United States
Peter MacCallum Cancer Centre
RECRUITING

Melbourne, 3000, Australia
Phramongkutklao Hospital
RECRUITING

Bangkok, 10400, Thailand
Prince of Wales Hospital
RECRUITING

Shatin, Hong Kong
Princess Margaret Cancer Centre
RECRUITING

Toronto, Ontario, M5G 1L7, Canada
Queen Elizabeth Hospital
RECRUITING

Hong Kong, Hong Kong
Queen Mary Hospital Department of Medicine
RECRUITING

Hong Kong, 999077, Hong Kong
Radboud University Medical Center
RECRUITING

Nijmegen, 6525 GA, Netherlands
Rajavithi Hospital
RECRUITING

Din Daeng, 10400, Thailand
Ramathibodi Hospital, Mahidol University
RECRUITING

Bangkok, 10400, Thailand
Rocky Mountain Cancer Centers
RECRUITING

Boulder, Colorado, 80218, United States
Royal Free London NHS Foundation Trust
RECRUITING

Hampstead, NW3 2QG, United Kingdom
Royal Surrey County Hospital
RECRUITING

Guildford, GU2 7XX, United Kingdom
SCRI Oncology Partners
RECRUITING

Nashville, Tennessee, 37203, United States
Samsung Medical Center
RECRUITING

Seoul, 06351, South Korea
Sanatorio Allende
RECRUITING

Córdoba, 5000, Argentina
Sanatorio Parque S.A.
RECRUITING

Rosario, Santa Fe Province, S20000DSV, Argentina
Santa Casa de Misericordia de Belo Horizonte
RECRUITING

Belo Horizonte, 30150, Brazil
Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Severance Hospital Yonsei Cancer Center
RECRUITING

Seoul, 03722, South Korea
Shizuoka Cancer Center
RECRUITING

Nagaizumi-chō, 411-0934, Japan
Siriraj Hospital Mahidol University
RECRUITING

Bangkok, 10700, Thailand
Sotiria Thoracic Diseases Hospital of Athens
RECRUITING

Athens, 115 27, Greece
Sunway Medical Centre
RECRUITING

Subang Jaya, 47500, Malaysia
Sylvester Comprehensive Cancer Center Miami
RECRUITING

Miami, Florida, 33136, United States
Szpital Specjalistyczny w Brzozowie
RECRUITING

Brzozów, 36-200, Poland
Tan Tock Seng Hospital
RECRUITING

Singapore, 308433, Singapore
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
RECRUITING

Tokyo, 135-8550, Japan
The Christie NHS Foundation Trust
RECRUITING

Manchester, M20 4BX, United Kingdom
The Ohio State University
RECRUITING

Columbus, Ohio, 43210, United States
The Royal Marsden NHS Foundation Trust
RECRUITING

London, SW3 6JJ, United Kingdom
UOMi Cancer Center
RECRUITING

Barcelona, 08017, Spain
UZ Leuven
RECRUITING

Leuven, 3000, Belgium
University General Hospital of Larissa
RECRUITING

Larissa, 411 10, Greece
University Medical Center Utrecht
RECRUITING

Utrecht, 3584, Netherlands
University of California, Irvine Health
RECRUITING

Orange, California, 92868, United States
University of Cincinnati Cancer Center
RECRUITING

Cincinnati, Ohio, 45267, United States
University of Southern Denmark
RECRUITING

Odense, 5000, Denmark
University of Washington - Fred Hutchinson Cancer Center
RECRUITING

Seattle, Washington, 98109, United States
Uniwersyteckie Centrum Kliniczne
RECRUITING

Gdansk, 80-952, Poland
Virginia Cancer Specialists
RECRUITING

Fairfax, Virginia, 22031, United States
Wakayama Medical University Hospital
RECRUITING

Wakayama, 641-0012, Japan
Washington University Center for Advanced Medicine
RECRUITING

St Louis, Missouri, 63110, United States
Westmead Hospital
RECRUITING

Westmead, New South Wales, 2145, Australia
Wiener Gesundheitsverbund
RECRUITING

Vienna, 1210, Austria
Winship Cancer Institute of Emory University
RECRUITING

Atlanta, Georgia, 30322, United States
Zanamed Medical Clinic Sp. z o.o.
RECRUITING

Lublin, 20-601, Poland

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