AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3ALKAZARNCT06765109

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

A Phase 3 study testing Neladalkib (NVL-655) and Alectinib in people with Non-small Cell Lung Cancer and Anaplastic Lymphoma Kinase-positive, run by Nuvalent Inc. at 159 sites in 29 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Neladalkib (NVL-655) and Alectinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
159 sitesin 29 countries
Study dates
17 Jul 2025to Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)
  • Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood
  • No prior systemic anticancer treatment for NSCLC (adjuvant/neoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor [TKI] such as alectinib is not allowed in any setting)
  • Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
  • Pretreatment tumor tissue

Who cannot join

  • Patient's cancer has a known oncogenic driver alteration other than ALK.
  • Known allergy/hypersensitivity to excipients of neladalkib or alectinib.
  • Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization
  • Major surgery within 4 weeks prior to randomization
  • Uncontrolled clinically relevant infection requiring systemic therapy
  • Known active tuberculosis, or active Hepatitis B or C
Show all 10Show fewer
  • QT corrected for heart rate by Fridericia's formula (QTcF) > 470 msec on repeated assessments
  • Clinically significant cardiovascular disease
  • Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease
  • Active malignancy requiring therapy within 2 years prior to randomization

Trial locations and contacts

159 sites in 29 countries. Contact the study team or a site near you to ask about taking part.

Nuvalent Clinical Trials contact

857-357-7000

clinicaltrials@nuvalent.com

159 sites in 29 countries

United States23 sites, 22 recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

    Ticiana Leal, M.D.

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Alice Shaw, M.D., Ph.D.

    Recruiting

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80218

    Robert Jotte, MD, PhD

    Recruiting

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

    Daniel Haggstrom, MD

    Recruiting

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45267

    Jennifer Leddon, M.D., Ph.D.

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Logan Roof, M.D., MSCR

    Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Withdrawn

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Thomas Stinchcombe, M.D.

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Alexander Spira, M.D., Ph.D.

    Recruiting

  • Palo Verde Hematology Oncology

    Glendale, Arizona, 85304

    Amol Nanak Singh Rakkar, M.D.

    Recruiting

  • Sylvester Comprehensive Cancer Center Miami

    Miami, Florida, 33136

    Gilberto de Lima Lopes, Jr., M.D.

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Melissa Johnson, M.D.

    Recruiting

  • NYU Langone's Perlmutter Cancer Center

    New York, New York, 10016

    Elaine Shum, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Alexander Drilon, M.D.

    Recruiting

  • Hoag Hospital Newport Beach

    Newport Beach, California, 92663

    Yaser Homsi, MD

    Recruiting

  • University of California, Irvine Health

    Orange, California, 92868

    Misako Nagasaka, M.D., Ph.D.

    Recruiting

  • AdventHealth Cancer Institute

    Orlando, Florida, 32804

    Mark Socinski, M.D.

    Recruiting

  • University of Washington - Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Christina Baik, MD

    Recruiting

  • Alliance Cancer Specialists

    Sellersville, Pennsylvania, 18960

    Howard Zipin, MD

    Recruiting

  • Washington University Center for Advanced Medicine

    St Louis, Missouri, 63110

    Ayse Ece Cali Daylan, M.D.

    Recruiting

  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

    Ben Creelan, M.D.

    Recruiting

  • Compass Oncology

    Vancouver, Washington, 98684

    Anthony Van Ho, MD

    Recruiting

  • Optum Medical Care, PC

    Westbury, New York, 11590

    Jonathan S. Goldberg, M.D.

    Recruiting

Other trials in United States

Italy12 sites, 12 recruiting

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, 60126

    Rossana Berardi, M.D.

    Recruiting

  • IRCCS Istituto Tumori Giovanni Paolo II

    Bari, 70124

    Domenico Galetta, M.D.

    Recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    Meldola, 47014

    Angelo Delmonte, M.D.

    Recruiting

  • Istituto Clinico Humanitas

    Milan, 20089

    Giovanna Finocchiaro, M.D.

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Arsela Prelaj, MD

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    Gianluca Spitaleri, M.D.

    Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900

    Diego Cortinovis, MD

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

    Antonio Chella, MD

    Recruiting

  • AUSL Della Romagna - Ospedale Santa Maria delle Croci

    Ravenna, 48121

    Chiara Bennati, M.D.

    Recruiting

  • Istituti Fisioterapici Ospitalieri - IRCCS Istituto Nazionale Tumori Regina Elena

    Roma, 00144

    Lorenza Landi, M.D.

    Recruiting

  • ASL Taranto Ospedale S. G. Moscati

    Statte, 74010

    Salvatore Pisconti, MD

    Recruiting

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

    Torino, 10060

    Vanesa Gregorc, M.D.

    Recruiting

Other trials in Italy

France10 sites, 10 recruiting

  • Centre Hospitalier Universitaire d' Angers

    Angers, 49000

    Youssef Oulkhouir, M.D.

    Recruiting

  • Institut Bergonie

    Bordeaux, 33000

    Sophie Cousin, M.D.

    Recruiting

  • Centre Francois Baclesse

    Caen, 14076

    Hubert Curcio, M.D.

    Recruiting

  • Centre Leon Berard

    Lyon, 69373

    Aurelie Swalduz, M.D.

    Recruiting

  • Hospital Nord

    Marseille, 13015

    Pascale Tomasini, M.D.

    Recruiting

  • Institut Regional du Cancer de Montpellier

    Montpellier, 34298

    Xavier Quantin, M.D., Ph.D.

    Recruiting

  • Centre Hospitalier Universitaire (CHU) Nantes Hopital Nord Laennec

    Nantes, 44093

    Elvire Pons-Tostivint, M.D., Ph.D.

    Recruiting

  • APHP - Hôpital Tenon

    Paris, 75020

    Jacques Cadranel, MD

    Recruiting

  • Centre Hospitalier Universitaire (CHU) de Bordeaux

    Pessac, 33604

    Remi Veillon, M.D.

    Recruiting

  • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

    Toulouse, 31059

    Julien Mazieres, M.D., Ph.D.

    Recruiting

Other trials in France

Japan10 sites, 10 recruiting

  • Aichi Cancer Center

    Chikusa, 464-8681

    Teppei Yamaguchi, MD

    Recruiting

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

    Isamu Okamoto, M.D., Prof.

    Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-chō, 411-0934

    Ryo Ko, MD

    Recruiting

  • Okayama University Hospital

    Okayama, 700-8558

    Kiichiro Ninomiya, MD

    Recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567

    Kazumi Nishino, MD

    Recruiting

  • Kindai University Hospital

    Sakai, 590-0197

    Tanizaki Junko, MD

    Recruiting

  • National Cancer Center Hospital

    Tokyo, 1040045

    Hiroshi Yoshida, MD

    Recruiting

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Tokyo, 135-8550

    Ryo Ariyasu, M.D.

    Recruiting

  • Wakayama Medical University Hospital

    Wakayama, 641-0012

    Hiroaki Akamatsu, MD

    Recruiting

  • Kanagawa Cancer Center

    Yokohama, 241-8515

    Shuhei Teranishi, M.D.

    Recruiting

Other trials in Japan

Spain10 sites, 10 recruiting

  • Complejo Hospitalario Universitario a Coruña

    A Coruña, 15006

    Maria Rosario Garcia Campelo, M.D.

    Recruiting

  • ICO Badalona H.U. Germans Trias i Pujol

    Badalona, 08916

    Teresa Moran, MD

    Recruiting

  • UOMi Cancer Center

    Barcelona, 08017

    Santiago Viteri Ramirez, M.D.

    Recruiting

  • Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007

    Elia Sais Girona, MD

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Antonio Calles Blanco, MD

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Pilar Garrido Lopez, M.D., Ph.D.

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Luis Gonzaga Paz-Area Rodriguez, M.D., Ph.D.

    Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

    Manuel Cobo Dols, MD

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Teresa Carcia Manrique, M.D.

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Miriam Alonso Garcia, M.D.

    Recruiting

Other trials in Spain

Brazil8 sites, 8 recruiting

  • Fundação Pio XII

    Barretos, 14784

    Josiane Mourao Dias, MD

    Recruiting

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150

    Gilson Gabriel Veloso, MD

    Recruiting

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90035

    Katsuki Tiscoski, MD

    Recruiting

  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul

    Porto Alegre, 90610

    Ana Caroline Gelatti, MD

    Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base

    São José do Rio Preto, 15090

    Joao Antonio Soler, MD

    Recruiting

  • Instituto do Cancer do Estado de São Paulo ICESP

    São Paulo, 01246-000

    Milena Mak, MD

    Recruiting

  • A.C.Camargo Cancer Center

    São Paulo, 01509-010

    Vladmir Cordeiro de Lima, Ph.D.

    Recruiting

  • Hospital Amaral Carvalho

    São Paulo, 17210-080

    Patricia Medeiros Milhomem Beato, M.D.

    Recruiting

Other trials in Brazil

United Kingdom8 sites, 8 recruiting

  • Cambridge University Hospitals NHS Trust, Addenbrooke's Hospital

    Cambridge, NG5 1PB

    Nicola Thompson, M.D., Ph.D.

    Recruiting

  • Royal Surrey County Hospital

    Guildford, GU2 7XX

    Ajay Mehta, MD

    Recruiting

  • Royal Free London NHS Foundation Trust

    Hampstead, NW3 2QG

    Alexandra Pender, MB BChir, Ph.D.

    Recruiting

  • Guy's Cancer Centre NHS Foundation Trust

    London, SE1 9RT

    Sharmistha Ghosh, BMBCH

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

    Sanjay Popat, MBBS, Ph.D.

    Recruiting

  • Maidstone Hospital

    Maidstone, ME16 9QQ

    Riyaz Shah, MBBS, Ph.D.

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Raffaele Califano, M.D.

    Recruiting

  • Nottingham City Hospital

    Nottingham, NG5 1PB

    Jason Adhikaree, MBBS, Ph.D.

    Recruiting

Other trials in United Kingdom

Malaysia6 sites, 6 recruiting

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10450

    Cheen Leng Lee, MBBS, FRCR

    Recruiting

  • Hospital Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur, 50586

    Prathepamalar Yehgambaram, MBBS

    Recruiting

  • Hospital Umum Sarawak

    Kuching, 93586

    Pei Jye Voon, M.D.

    Recruiting

  • Beacon International Specialist Centre

    Petaling Jaya, Selangor, 46050

    Mohamed Ibrahim A Wahid, MBBCh

    Recruiting

  • Institut Kanser Negara

    Putrajaya, Putrajaya, 62250

    Suhana Yusak, MBBS

    Recruiting

  • Sunway Medical Centre

    Subang Jaya, 47500

    Dai Wee Lee, MD

    Recruiting

Other trials in Malaysia

Mexico6 sites, 6 recruiting

  • Health Pharma Professional Research S.A de C.V.

    Mexico City, 03100

    Jorge Alatorre Alexander, MD

    Recruiting

  • Centro Oncológico Personalizado

    Mexico City, 06760

    Nora Chavez Hernandez, MD

    Recruiting

  • Instituto Nacional de Cancerologia

    Mexico City, 14080

    David Davila Dupont, MD

    Recruiting

  • Hospital Universitario Dr. Jose Eleuterio González

    Monterrey, 64660

    Victor Oyervides Juarez, MD

    Recruiting

  • Centro de Investigacion Clinica Chapultepec S.A. de C.V.

    Morelia, 58260

    Leticia Vazquez Cortes, MD

    Recruiting

  • Oncologia Integral Satelite S. A. de C. V.

    Naucalpan, 53100

    Osvaldo Hernandez Flores, MD

    Recruiting

Other trials in Mexico

South Korea6 sites, 6 recruiting

  • Chungbuk National University Hospital

    Cheongju-si, 28644

    Ki Hyeong Lee, M.D.

    Recruiting

  • Center for Lung Cancer, National Cancer Center

    Goyang-si, 10408

    Ji-Youn Han, M.D., Ph.D.

    Recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565

    Joo-Hwan Park, M.D., Ph.D.

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Dong-Wan Kim, M.D.

    Recruiting

  • Severance Hospital Yonsei Cancer Center

    Seoul, 03722

    Min Hee Hong, M.D.

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Myung-Ju Ahn, M.D., Ph.D.

    Recruiting

Other trials in South Korea

Thailand6 sites, 6 recruiting

  • Phramongkutklao Hospital

    Bangkok, 10400

    Naiyarat Prasongsook, M.D.

    Recruiting

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

    Thanyanan Baisamut, M.D., M.Sc.

    Recruiting

  • Siriraj Hospital Mahidol University

    Bangkok, 10700

    Pongwut Banchaivijitr, M.D.

    Recruiting

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

    Chaiyut Charoentum, M.D.

    Recruiting

  • Rajavithi Hospital

    Din Daeng, 10400

    Kunlatida Maneenil, MD

    Recruiting

  • HRH Princess Maha Chakri Sirindhorn Medical Center

    Ongkharak, 26120

    Supagone Wangsubtawee, M.D.

    Recruiting

Other trials in Thailand

Germany5 sites, 5 recruiting

  • Helios Klinikum Emil von Behring GmbH

    Berlin, 14165

    Jens Kollmeier, Dr. med.

    Recruiting

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, 73730

    Martin Faehling, PD M.D. MsC

    Recruiting

  • LungenClinic Grosshansdorf GmBH

    Großhansdorf, D-22927

    Martin Reck, Prof, M.D.

    Recruiting

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

    Achim Rittmeyer, M.D.

    Recruiting

  • MVZ Onkologie Velbert

    Velbert, 42551

    Arnd Nusch, Dr. med.

    Recruiting

Other trials in Germany

Greece5 sites, 5 recruiting

  • Henry Dunant Hospital Center

    Athens, 115 26

    Ioannis Mountzios, M.D., Ph.D.

    Recruiting

  • Sotiria Thoracic Diseases Hospital of Athens

    Athens, 115 27

    Konstantinos Syrigos, M.D.

    Recruiting

  • University General Hospital of Larissa

    Larissa, 411 10

    Athanasios Kotsakis, M.D., Ph.D.

    Recruiting

  • Athens Medical Center

    Marousi, 151 25

    Vasileios Ramfidis, M.D., Ph.D.

    Recruiting

  • GENESIS General Clinic

    Thessaloniki, 555 35

    Ioannis Boukovinas, M.D., Ph.D.

    Recruiting

Other trials in Greece

Chile4 sites, 4 recruiting

  • Fundacion Arturo Lopez Perez FALP

    Providencia, 7500000

    Christian Caglevic Medina, MD

    Recruiting

  • Centro de Oncologia de Precision de la Universidad Mayor

    Santiago, 5750

    Pamela Salman, MD

    Recruiting

  • Centro de Investigaciones Clinicas UC CICUC

    Santiago, 8320000

    Hector Gonzalo Galindo Aranibar, MD

    Recruiting

  • Oncovida - Santiago

    Santiago, 8320000

    Ariel Zwenger, MD

    Recruiting

Other trials in Chile

Hungary4 sites, 4 recruiting

  • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

    Debrecen, 4032

    Ildiko Horvath, M.D., Ph.D.

    Recruiting

  • Matrai Gyogyintezet

    Gyöngyös, 7151

    Istvan Albert, M.D.

    Recruiting

  • Bekes Varmegyei Kozponti Korhaz

    Gyula, 5703

    Ibolya Laczó, MD

    Recruiting

  • Bacs-Kiskun Varmegyei Oktatokorhaz

    Kecskemét, 6000

    Zsuzsanna Kelemen, M.D.

    Recruiting

Other trials in Hungary

Poland4 sites, 4 recruiting

  • Szpital Specjalistyczny w Brzozowie

    Brzozów, 36-200

    Dariusz Sawka, M.D.

    Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

    Anna Wrona, MD

    Recruiting

  • Zanamed Medical Clinic Sp. z o.o.

    Lublin, 20-601

    Ludmila Grzybowska-Szatkowska, M.D., Ph.D.

    Recruiting

  • One Day Med

    Szczecin, 70-419

    Piotr Serwatowski, M.D., Ph.D.

    Recruiting

Other trials in Poland

Portugal4 sites, 4 recruiting

  • Hospital de Cascais

    Alcabideche, 2755-009

    Diogo D'Alpium Costa, M.D.

    Recruiting

  • Fundacao Champalimaud

    Lisbon, 1400-038

    Marcos Pantarotto, M.D.

    Recruiting

  • CUF Porto Hospital

    Porto, 4100-180

    Venceslau Hespanhol, M.D., Ph.D.

    Recruiting

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.

    Porto, 4200-072

    Marta Soares, M.D.

    Recruiting

Other trials in Portugal

Taiwan4 sites, 4 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

    Jen-Yu Hung, M.D., Ph.D.

    Recruiting

  • Chung Shan Medical University

    Taichung, 40201

    Gee-Chen Chang, M.D., Ph.D.

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 70403

    Chien-Chung Lin, M.D., Ph.D.

    Recruiting

  • National Taiwan University Hospital

    Taipei

    Chia-Chi Lin, M.D., Ph.D.

    Recruiting

Other trials in Taiwan

Argentina3 sites, 3 recruiting

  • Sanatorio Allende

    Córdoba, 5000

    Ignacio Jerez, M.D.

    Recruiting

  • Centro Médico Privado CEMIC

    Córdoba, X5008

    Luigi Pirelli, MD

    Recruiting

  • Sanatorio Parque S.A.

    Rosario, Santa Fe Province, S20000DSV

    Gaston Martinengo, M.D.

    Recruiting

Other trials in Argentina

Australia3 sites, 3 recruiting

  • Austin Health

    Heidelberg, Victoria, 3084

    Sagun Parakh, M.D.

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

    Benjamin Solomon, MBBS, Ph.D.

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Pei Ding, MB BChir, Ph.D.

    Recruiting

Other trials in Australia

Belgium3 sites, 3 recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

    Frank Aboubakar Nana, M.D., Ph.D.

    Recruiting

  • Antwerp University Hospital

    Edegem, 2650

    Jo Raskin, M.D.

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Christophe Dooms, M.D., Ph.D.

    Recruiting

Other trials in Belgium

Denmark3 sites, 3 recruiting

  • Aarhus Universitetshospital

    Aarhus, 8200

    Peter Meldgaard, MD

    Recruiting

  • Herlev and Gentofte Hospital

    Herlev, 02730

    Rikke Andersen, M.D., Ph.D.

    Recruiting

  • University of Southern Denmark

    Odense, 5000

    Lotte Holm Land, M.D., Ph.D.

    Recruiting

Other trials in Denmark

Hong Kong3 sites, 3 recruiting

  • Queen Mary Hospital Department of Medicine

    Hong Kong, 999077

    James Chung-man Ho, MBBS, M.D.

    Recruiting

  • Queen Elizabeth Hospital

    Hong Kong

    Kam-hung Wong, MB. Ch.B.

    Recruiting

  • Prince of Wales Hospital

    Shatin

    Herbert Loong, M.D.

    Recruiting

Other trials in Hong Kong

Netherlands3 sites, 3 recruiting

  • Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX

    Joop de Langen, MSc, Ph.D.

    Recruiting

  • Radboud University Medical Center

    Nijmegen, 6525 GA

    Michel Van der Drift, M.D., Ph.D.

    Recruiting

  • University Medical Center Utrecht

    Utrecht, 3584

    Anne van Lindert, M.D.

    Recruiting

Other trials in Netherlands

Singapore2 sites, 2 recruiting

  • National Cancer Centre Singapore

    Singapore, 168583

    Gillianne Lai, MBBS

    Recruiting

  • Tan Tock Seng Hospital

    Singapore, 308433

    Puey Ling Chia, MBBS

    Recruiting

Other trials in Singapore

Austria1 site, 1 recruiting

  • Wiener Gesundheitsverbund

    Vienna, 1210

    Maximilian Hochmair, MD

    Recruiting

Other trials in Austria

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1L7

    Geoffrey Liu, M.D.

    Recruiting

Other trials in Canada

Czechia1 site, 1 recruiting

  • Nemocnice AGEL Nový Jičín a.s.

    Nový Jičín, 74101

    Vojtech Tlusty, MUDr.

    Recruiting

Other trials in Czechia

Switzerland1 site, 1 recruiting

  • Luzerner Kantonsspital

    Lucerne, 6004

    Anna Allemann, MD

    Recruiting

Other trials in Switzerland

About this study

Official title: A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)

Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).

Read the detailed description

Patients will be randomized in a 1:1 ratio (approximately 225 in each arm) to receive either neladalkib (NVL-655) or alectinib.

Being tested
Neladalkib (NVL-655), Alectinib
Keywords
NSCLC, Lung cancer, Lung neoplasms, Lung diseases, ALK positive NSCLC, TKI naive, ALK TKI naive, Treatment naive
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neladalkib (NVL-655)Drug

    Oral tablet of Neladalkib (NVL-655)

  • AlectinibDrug

    Also called Alecensa

    Oral capsule of alectinib

Study groups in NCT06765109
Study groupRoleWhat they receive
Neladalkib (NVL-655)Experimental150mg taken orally once daily (QD)
Receives: Drug: Neladalkib (NVL-655)
AlectinibActive comparator600mg taken orally twice daily (BID)
Receives: Drug: Alectinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) per blinded independent central review (BICR)

    Time from randomization to BICR-assessed radiographic disease progression or death

    Measured: Up to 5 years after first patient dosed

Secondary outcomes (12)

  1. Overall survival (OS)

    Time from randomization to death

    Measured: Up to 5 years after first patient dosed

  2. Progression-free survival (PFS) per investigator assessment

    Time from randomization to investigator-assessed radiographic disease progression or death

    Measured: Up to 5 years after first patient dosed

  3. Time to intracranial progression per BICR

    Time from randomization to the first BICR-assessed occurrence of disease progression in the central nervous system (CNS)

    Measured: Up to 5 years after first patient dosed

  4. Intracranial objective response rate (IC-ORR)

    Proportion of patients with a confirmed intracranial response (intracranial complete response [IC-CR] or intracranial partial response [IC-PR]) among patients with measurable CNS disease at baseline

    Measured: Up to 5 years after first patient dosed

  5. Intracranial duration of response (IC-DOR)

    Time from first intracranial response (IC-CR or IC-PR) to radiographic intracranial disease progression or death

    Measured: Up to 5 years after first patient dosed

  6. Objective response rate (ORR)

    Proportion of patients with a complete response or partial response

    Measured: Up to 5 years after first patient dosed

  7. Duration of response (DOR)

    Time from first response (complete or partial) to radiographic disease progression or death

    Measured: Up to 5 years after first patient dosed

  8. Intracranial progression per investigator assessment

    Time to investigator-assessed intracranial progression

    Measured: Up to 5 years after first patient dosed

  9. Treatment-emergent adverse events (TEAEs) and changes in clinically relevant laboratory parameters

    Incidence and severity of TEAEs and changes in clinically relevant laboratory parameters

    Measured: Up to 5 years after first patient dosed

  10. Patient-reported measures in health-related quality of life (QoL)

    Changes in patient-reported outcomes (PROs) assessed by the European Organization for Research and Treatment of Cancer QoL core questionnaire - Cancer (EORTC QLQ-C30)

    Measured: Up to 5 years after first patient dosed

  11. Patient-reported measures in lung cancer symptoms and side effects of treatment

    Changes in PROs assessed by the European Organization for Research and Treatment of Cancer QoL - Lung Cancer module (EORTC QLQ-LC29)

    Measured: Up to 5 years after first patient dosed

  12. Patient-reported measures in patient functioning

    Changes in PROs assessed by the European Quality of Life (EuroQol) 5-dimension questionnaire (EQ-5D-5L)

    Measured: Up to 5 years after first patient dosed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start17 Jul 2025
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06765109
Sponsor's protocol ID
NVL-655-04
Other IDs
2024-517553-26
Acronym
ALKAZAR
Status last verified
Aug 2026
First submitted
8 Nov 2024
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neladalkib (NVL-655) and Alectinib in people with Non-small Cell Lung Cancer and Anaplastic Lymphoma Kinase-positive, run by Nuvalent Inc. at 159 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 159 sites in United States, Italy, France, Japan, Spain and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nuvalent Clinical Trials (857-357-7000, clinicaltrials@nuvalent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) per blinded independent central review (BICR) (time frame: Up to 5 years after first patient dosed). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06765109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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