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

May 29, 2026 updated by: Nuvalent Inc.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Córdoba, Argentina, 5000
        • Recruiting
        • Sanatorio Allende
        • Principal Investigator:
          • Ignacio Jerez, M.D.
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S20000DSV
        • Recruiting
        • Sanatorio Parque S.A.
        • Principal Investigator:
          • Gaston Martinengo, M.D.
  • Australia
      • Melbourne, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Principal Investigator:
          • Benjamin Solomon, MBBS, Ph.D.
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Principal Investigator:
          • Pei Ding, MB BChir, Ph.D.
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health
        • Principal Investigator:
          • Sagun Parakh, M.D.
  • Austria
      • Vienna, Austria, 1210
        • Recruiting
        • Wiener Gesundheitsverbund
        • Principal Investigator:
          • Maximilian Hochmair, MD
  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-luc
        • Principal Investigator:
          • Frank Aboubakar Nana, M.D., Ph.D.
      • Edegem, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital
        • Principal Investigator:
          • Jo Raskin, M.D.
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Principal Investigator:
          • Christophe Dooms, M.D., Ph.D.
  • Brazil
      • Barretos, Brazil, 14784
        • Recruiting
        • Fundacao Pio XII
        • Principal Investigator:
          • Josiane Mourao Dias, MD
      • Belo Horizonte, Brazil, 30150
        • Recruiting
        • Santa Casa de Misericordia de Belo Horizonte
        • Principal Investigator:
          • Gilson Gabriel Veloso, MD
      • Porto Alegre, Brazil, 90035
        • Recruiting
        • Irmandade da Santa Casa de Misericordia de Porto Alegre
        • Principal Investigator:
          • Katsuki Tiscoski, MD
      • Porto Alegre, Brazil, 90610
        • Recruiting
        • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
        • Principal Investigator:
          • Ana Caroline Gelatti, MD
      • São José do Rio Preto, Brazil, 15090
        • Recruiting
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
        • Principal Investigator:
          • Joao Antonio Soler, MD
      • São Paulo, Brazil, 01246-000
        • Recruiting
        • Instituto do Cancer do Estado de São Paulo ICESP
        • Principal Investigator:
          • Milena Mak, MD
      • São Paulo, Brazil, 01509-010
        • Recruiting
        • A.C.Camargo Cancer Center
        • Principal Investigator:
          • Vladmir Cordeiro de Lima, Ph.D.
      • São Paulo, Brazil, 17210-080
        • Recruiting
        • Hospital Amaral Carvalho
        • Principal Investigator:
          • Patricia Medeiros Milhomem Beato, M.D.
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1L7
        • Recruiting
        • Princess Margaret Cancer Centre
        • Principal Investigator:
          • Geoffrey Liu, M.D.
  • Chile
      • Providencia, Chile, 7500000
        • Recruiting
        • Fundacion Arturo Lopez Perez FALP
        • Principal Investigator:
          • Christian Caglevic Medina, MD
      • Santiago, Chile, 8320000
        • Recruiting
        • Centro de Investigaciones Clinicas UC CICUC
        • Principal Investigator:
          • Hector Gonzalo Galindo Aranibar, MD
      • Santiago, Chile, 8320000
        • Recruiting
        • Oncovida - Santiago
        • Principal Investigator:
          • Ariel Zwenger, MD
      • Santiago, Chile, 5750
        • Recruiting
        • Centro de Oncologia de Precision de la Universidad Mayor
        • Principal Investigator:
          • Pamela Salman, MD
  • Czechia
      • Nový Jičín, Czechia, 74101
        • Recruiting
        • Nemocnice AGEL Nový Jičín a.s.
        • Principal Investigator:
          • Vojtech Tlusty, MUDr.
  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital
        • Principal Investigator:
          • Peter Meldgaard, MD
      • Herlev, Denmark, 02730
        • Recruiting
        • Herlev and Gentofte Hospital
        • Principal Investigator:
          • Rikke Andersen, M.D., Ph.D.
      • Odense, Denmark, 5000
        • Recruiting
        • University of Southern Denmark
        • Principal Investigator:
          • Lotte Holm Land, M.D., Ph.D.
  • France
      • Angers, France, 49000
        • Recruiting
        • Centre Hospitalier Universitaire d' Angers
        • Principal Investigator:
          • Youssef Oulkhouir, M.D.
      • Bordeaux, France, 33000
        • Recruiting
        • Institut Bergonie
        • Principal Investigator:
          • Sophie Cousin, M.D.
      • Caen, France, 14076
        • Recruiting
        • Centre Francois Baclesse
        • Principal Investigator:
          • Hubert Curcio, M.D.
      • Lyon, France, 69373
        • Recruiting
        • Centre Léon Bérard
        • Principal Investigator:
          • Aurelie Swalduz, M.D.
      • Marseille, France, 13015
        • Recruiting
        • Hospital Nord
        • Principal Investigator:
          • Pascale Tomasini, M.D.
      • Montpellier, France, 34298
        • Recruiting
        • Institut Regional du Cancer de Montpellier
        • Principal Investigator:
          • Xavier Quantin, M.D., Ph.D.
      • Nantes, France, 44093
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) Nantes Hopital Nord Laennec
        • Principal Investigator:
          • Elvire Pons-Tostivint, M.D., Ph.D.
      • Paris, France, 75020
        • Recruiting
        • APHP - Hôpital Tenon
        • Principal Investigator:
          • Jacques Cadranel, MD
      • Pessac, France, 33604
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Bordeaux
        • Principal Investigator:
          • Remi Veillon, M.D.
      • Toulouse, France, 31059
        • Recruiting
        • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
        • Principal Investigator:
          • Julien Mazieres, M.D., Ph.D.
  • Germany
      • Berlin, Germany, 14165
        • Recruiting
        • Helios Klinikum Emil von Behring GmbH
        • Principal Investigator:
          • Jens Kollmeier, Dr. med.
      • Esslingen am Neckar, Germany, 73730
        • Recruiting
        • Klinikum Esslingen GmbH
        • Principal Investigator:
          • Martin Faehling, PD M.D. MsC
      • Großhansdorf, Germany, D-22927
        • Recruiting
        • LungenClinic Grosshansdorf GmbH
        • Principal Investigator:
          • Martin Reck, Prof, M.D.
      • Immenhausen, Germany, 34376
        • Recruiting
        • Lungenfachklinik Immenhausen
        • Principal Investigator:
          • Achim Rittmeyer, M.D.
      • Velbert, Germany, 42551
        • Recruiting
        • MVZ Onkologie Velbert
        • Principal Investigator:
          • Arnd Nusch, Dr. med.
  • Greece
      • Athens, Greece, 115 26
        • Recruiting
        • Henry Dunant Hospital Center
        • Principal Investigator:
          • Ioannis Mountzios, M.D., Ph.D.
      • Athens, Greece, 115 27
        • Recruiting
        • Sotiria Thoracic Diseases Hospital of Athens
        • Principal Investigator:
          • Konstantinos Syrigos, M.D.
      • Larissa, Greece, 411 10
        • Recruiting
        • University General Hospital of Larissa
        • Principal Investigator:
          • Athanasios Kotsakis, M.D., Ph.D.
      • Marousi, Greece, 151 25
        • Recruiting
        • Athens Medical Center
        • Principal Investigator:
          • Vasileios Ramfidis, M.D., Ph.D.
      • Thessaloniki, Greece, 555 35
        • Recruiting
        • GENESIS General Clinic
        • Principal Investigator:
          • Ioannis Boukovinas, M.D., Ph.D.
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Elizabeth Hospital
        • Principal Investigator:
          • Kam-hung Wong, MB. Ch.B.
      • Hong Kong, Hong Kong, 999077
        • Recruiting
        • Queen Mary Hospital Department of Medicine
        • Principal Investigator:
          • James Chung-man Ho, MBBS, M.D.
      • Shatin, Hong Kong
        • Recruiting
        • Prince of Wales Hospital
        • Principal Investigator:
          • Herbert Loong, M.D.
  • Hungary
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
        • Principal Investigator:
          • Ildiko Horvath, M.D., Ph.D.
      • Gyöngyös, Hungary, 7151
        • Recruiting
        • Matrai Gyogyintezet
        • Principal Investigator:
          • Istvan Albert, M.D.
      • Kecskemét, Hungary, 6000
        • Recruiting
        • Bács-Kiskun Vármegyei Oktatókórház
        • Principal Investigator:
          • Zsuzsanna Kelemen, M.D.
  • Italy
      • Ancona, Italy, 60126
        • Recruiting
        • Azienda Ospedaliero Universitaria delle Marche
        • Principal Investigator:
          • Rossana Berardi, M.D.
      • Bari, Italy, 70124
        • Recruiting
        • IRCCS Istituto Tumori Giovanni Paolo II
        • Principal Investigator:
          • Domenico Galetta, M.D.
      • Meldola, Italy, 47014
        • Recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
        • Principal Investigator:
          • Angelo Delmonte, M.D.
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Principal Investigator:
          • Arsela Prelaj, MD
      • Milan, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Principal Investigator:
          • Giovanna Finocchiaro, M.D.
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia
        • Principal Investigator:
          • Gianluca Spitaleri, M.D.
      • Monza, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
        • Principal Investigator:
          • Diego Cortinovis, MD
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Principal Investigator:
          • Antonio Chella, MD
      • Ravenna, Italy, 48121
        • Recruiting
        • AUSL Della Romagna - Ospedale Santa Maria delle Croci
        • Principal Investigator:
          • Chiara Bennati, M.D.
      • Roma, Italy, 00144
        • Recruiting
        • Istituti Fisioterapici Ospitalieri - IRCCS Istituto Nazionale Tumori Regina Elena
        • Principal Investigator:
          • Lorenza Landi, M.D.
      • Statte, Italy, 74010
        • Recruiting
        • ASL Taranto Ospedale S. G. Moscati
        • Principal Investigator:
          • Salvatore Pisconti, MD
      • Torino, Italy, 10060
        • Recruiting
        • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
        • Principal Investigator:
          • Vanesa Gregorc, M.D.
  • Japan
      • Chikusa, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center
        • Principal Investigator:
          • Teppei Yamaguchi, MD
      • Nagaizumi-chō, Japan, 411-0934
        • Recruiting
        • Shizuoka Cancer Center
        • Principal Investigator:
          • Ryo Ko, MD
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital
        • Principal Investigator:
          • Kiichiro Ninomiya, MD
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute
        • Principal Investigator:
          • Kazumi Nishino, MD
      • Sakai, Japan, 590-0197
        • Recruiting
        • Kindai University Hospital
        • Principal Investigator:
          • Tanizaki Junko, MD
      • Tokyo, Japan, 135-8550
        • Recruiting
        • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
        • Principal Investigator:
          • Ryo Ariyasu, M.D.
      • Tokyo, Japan, 1040045
        • Recruiting
        • National Cancer Center Hospital
        • Principal Investigator:
          • Hiroshi Yoshida, MD
      • Wakayama, Japan, 641-0012
        • Recruiting
        • Wakayama Medical University Hospital
        • Principal Investigator:
          • Hiroaki Akamatsu, MD
      • Yokohama, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center
        • Principal Investigator:
          • Shuhei Teranishi, M.D.
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Principal Investigator:
          • Isamu Okamoto, M.D., Prof.
  • Malaysia
      • Kuching, Malaysia, 93586
        • Recruiting
        • Hospital Umum Sarawak
        • Principal Investigator:
          • Pei Jye Voon, M.D.
      • Subang Jaya, Malaysia, 47500
        • Recruiting
        • Sunway Medical Centre
        • Principal Investigator:
          • Dai Wee Lee, MD
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
        • Recruiting
        • Hospital Kuala Lumpur
        • Principal Investigator:
          • Prathepamalar Yehgambaram, MBBS
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10450
        • Recruiting
        • Hospital Pulau Pinang
        • Principal Investigator:
          • Cheen Leng Lee, MBBS, FRCR
    • Putrajaya
      • Putrajaya, Putrajaya, Malaysia, 62250
        • Recruiting
        • Institut Kanser Negara
        • Principal Investigator:
          • Suhana Yusak, MBBS
    • Selangor
      • Petaling Jaya, Selangor, Malaysia, 46050
        • Recruiting
        • Beacon International Specialist Centre
        • Principal Investigator:
          • Mohamed Ibrahim A Wahid, MBBCh
  • Mexico
      • Mexico City, Mexico, 03100
        • Recruiting
        • Health Pharma Professional Research S.A de C.V.
        • Principal Investigator:
          • Jorge Alatorre Alexander, MD
      • Mexico City, Mexico, 06760
        • Recruiting
        • Centro Oncologico Personalizado
        • Principal Investigator:
          • Nora Chavez Hernandez, MD
      • Monterrey, Mexico, 64660
        • Recruiting
        • Hospital Universitario Dr. Jose Eleuterio González
        • Principal Investigator:
          • Victor Oyervides Juarez, MD
      • Morelia, Mexico, 58260
        • Recruiting
        • Centro de Investigacion Clinica Chapultepec S.A. de C.V.
        • Principal Investigator:
          • Leticia Vazquez Cortes, MD
      • Naucalpan, Mexico, 53100
        • Recruiting
        • Oncologia Integral Satelite S. A. de C. V.
        • Principal Investigator:
          • Osvaldo Hernandez Flores, MD
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
        • Principal Investigator:
          • Joop de Langen, MSc, Ph.D.
      • Nijmegen, Netherlands, 6525 GA
        • Recruiting
        • Radboud University Medical Center
        • Principal Investigator:
          • Michel Van der Drift, M.D., Ph.D.
      • Utrecht, Netherlands, 3584
        • Recruiting
        • University Medical Center Utrecht
        • Principal Investigator:
          • Anne van Lindert, M.D.
  • Poland
      • Brzozów, Poland, 36-200
        • Recruiting
        • Szpital Specjalistyczny w Brzozowie
        • Principal Investigator:
          • Dariusz Sawka, M.D.
      • Gdansk, Poland, 80-952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
        • Principal Investigator:
          • Anna Wrona, MD
      • Lublin, Poland, 20-601
        • Recruiting
        • Zanamed Medical Clinic Sp. z o.o.
        • Principal Investigator:
          • Ludmila Grzybowska-Szatkowska, M.D., Ph.D.
      • Szczecin, Poland, 70-419
        • Recruiting
        • One Day Med
        • Principal Investigator:
          • Piotr Serwatowski, M.D., Ph.D.
  • Portugal
      • Alcabideche, Portugal, 2755-009
        • Recruiting
        • Hospital de Cascais
        • Principal Investigator:
          • Diogo D'Alpium Costa, M.D.
      • Lisbon, Portugal, 1400-038
        • Recruiting
        • Fundacao Champalimaud
        • Principal Investigator:
          • Marcos Pantarotto, M.D.
      • Porto, Portugal, 4100-180
        • Recruiting
        • CUF Porto Hospital
        • Principal Investigator:
          • Venceslau Hespanhol, M.D., Ph.D.
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
        • Principal Investigator:
          • Marta Soares, M.D.
  • Singapore
      • Singapore, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital
        • Principal Investigator:
          • Puey Ling Chia, MBBS
      • Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore
        • Principal Investigator:
          • Gillianne Lai, MBBS
  • South Korea
      • Cheongju-si, South Korea, 28644
        • Recruiting
        • Chungbuk National University Hospital
        • Principal Investigator:
          • Ki Hyeong Lee, M.D.
      • Goyang-si, South Korea, 10408
        • Recruiting
        • Center for Lung Cancer, National Cancer Center
        • Principal Investigator:
          • Ji-Youn Han, M.D., Ph.D.
      • Incheon, South Korea, 21565
        • Recruiting
        • Gachon University Gil Medical Center
        • Principal Investigator:
          • Joo-Hwan Park, M.D., Ph.D.
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Dong-Wan Kim, M.D.
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Myung-Ju Ahn, M.D., Ph.D.
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital Yonsei Cancer Center
        • Principal Investigator:
          • Min Hee Hong, M.D.
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruña
        • Principal Investigator:
          • Maria Rosario Garcia Campelo, M.D.
      • Badalona, Spain, 08916
        • Recruiting
        • ICO Badalona H.U. Germans Trias i Pujol
        • Principal Investigator:
          • Teresa Moran, MD
      • Barcelona, Spain, 08017
        • Recruiting
        • UOMI Cancer Center
        • Principal Investigator:
          • Santiago Viteri Ramirez, M.D.
      • Girona, Spain, 17007
        • Recruiting
        • Hospital Universitari de Girona Dr Josep Trueta
        • Principal Investigator:
          • Elia Sais Girona, MD
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Principal Investigator:
          • Pilar Garrido Lopez, M.D., Ph.D.
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Luis Gonzaga Paz-Area Rodriguez, M.D., Ph.D.
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Principal Investigator:
          • Antonio Calles Blanco, MD
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga
        • Principal Investigator:
          • Manuel Cobo Dols, MD
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Miriam Alonso Garcia, M.D.
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Principal Investigator:
          • Teresa Carcia Manrique, M.D.
  • Switzerland
      • Lucerne, Switzerland, 6004
        • Recruiting
        • Luzerner Kantonsspital
        • Principal Investigator:
          • Anna Allemann, MD
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Principal Investigator:
          • Jen-Yu Hung, M.D., Ph.D.
      • Taichung, Taiwan, 40201
        • Recruiting
        • Chung Shan Medical University
        • Principal Investigator:
          • Gee-Chen Chang, M.D., Ph.D.
      • Tainan, Taiwan, 70403
        • Recruiting
        • National Cheng Kung University Hospital
        • Principal Investigator:
          • Chien-Chung Lin, M.D., Ph.D.
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Chia-Chi Lin, M.D., Ph.D.
  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital Mahidol University
        • Principal Investigator:
          • Pongwut Banchaivijitr, M.D.
      • Bangkok, Thailand, 10400
        • Recruiting
        • Phramongkutklao Hospital
        • Principal Investigator:
          • Naiyarat Prasongsook, M.D.
      • Bangkok, Thailand, 10400
        • Recruiting
        • Ramathibodi Hospital, Mahidol University
        • Principal Investigator:
          • Thanyanan Baisamut, M.D., M.Sc.
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital
        • Principal Investigator:
          • Chaiyut Charoentum, M.D.
      • Din Daeng, Thailand, 10400
        • Recruiting
        • Rajavithi Hospital
        • Principal Investigator:
          • Kunlatida Maneenil, MD
      • Ongkharak, Thailand, 26120
        • Recruiting
        • HRH Princess Maha Chakri Sirindhorn Medical Center
        • Principal Investigator:
          • Supagone Wangsubtawee, M.D.
  • United Kingdom
      • Cambridge, United Kingdom, NG5 1PB
        • Recruiting
        • Cambridge University Hospitals NHS Trust, Addenbrooke's Hospital
        • Principal Investigator:
          • Nicola Thompson, M.D., Ph.D.
      • Guildford, United Kingdom, GU2 7XX
        • Recruiting
        • Royal Surrey County Hospital
        • Principal Investigator:
          • Ajay Mehta, MD
      • Hampstead, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free London NHS Foundation Trust
        • Principal Investigator:
          • Alexandra Pender, MB BChir, Ph.D.
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • The Royal Marsden NHS Foundation Trust
        • Principal Investigator:
          • Sanjay Popat, MBBS, Ph.D.
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's Cancer Centre NHS Foundation Trust
        • Principal Investigator:
          • Sharmistha Ghosh, BMBCH
      • Maidstone, United Kingdom, ME16 9QQ
        • Recruiting
        • Maidstone Hospital
        • Principal Investigator:
          • Riyaz Shah, MBBS, Ph.D.
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie Nhs Foundation Trust
        • Principal Investigator:
          • Raffaele Califano, M.D.
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham City Hospital
        • Principal Investigator:
          • Jason Adhikaree, MBBS, Ph.D.
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Recruiting
        • Palo Verde Hematology Oncology
        • Principal Investigator:
          • Amol Nanak Singh Rakkar, M.D.
    • California
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Hospital Newport Beach
        • Principal Investigator:
          • Yaser Homsi, MD
      • Orange, California, United States, 92868
        • Recruiting
        • University of California, Irvine Health
        • Principal Investigator:
          • Misako Nagasaka, M.D., Ph.D.
    • Colorado
      • Boulder, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers
        • Principal Investigator:
          • Robert Jotte, MD, PhD
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center Miami
        • Principal Investigator:
          • Gilberto de Lima Lopes, Jr., M.D.
      • Orlando, Florida, United States, 32804
        • Recruiting
        • AdventHealth Cancer Institute
        • Principal Investigator:
          • Mark Socinski, M.D.
      • Tampa, Florida, United States, 33612
        • Recruiting
        • H Lee Moffitt Cancer Center and Research Institute
        • Principal Investigator:
          • Ben Creelan, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute of Emory University
        • Principal Investigator:
          • Ticiana Leal, M.D.
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Alice Shaw, M.D., Ph.D.
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Withdrawn
        • Barbara Ann Karmanos Cancer Institute
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University Center for Advanced Medicine
        • Principal Investigator:
          • Ayse Ece Cali Daylan, M.D.
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Alexander Drilon, M.D.
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone's Perlmutter Cancer Center
        • Principal Investigator:
          • Elaine Shum, MD
      • Westbury, New York, United States, 11590
        • Recruiting
        • Optum Medical Care, PC
        • Principal Investigator:
          • Jonathan S. Goldberg, M.D.
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center
        • Principal Investigator:
          • Daniel Haggstrom, MD
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Center
        • Principal Investigator:
          • Thomas Stinchcombe, M.D.
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati Cancer Center
        • Principal Investigator:
          • Jennifer Leddon, M.D., Ph.D.
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Principal Investigator:
          • Logan Roof, M.D., MSCR
    • Pennsylvania
      • Sellersville, Pennsylvania, United States, 18960
        • Recruiting
        • Alliance Cancer Specialists
        • Principal Investigator:
          • Howard Zipin, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
        • Principal Investigator:
          • Melissa Johnson, M.D.
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists
        • Principal Investigator:
          • Alexander Spira, M.D., Ph.D.
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington - Fred Hutchinson Cancer Center
        • Principal Investigator:
          • Christina Baik, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)
  2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood
  3. 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)
  4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
  5. Pretreatment tumor tissue

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alectinib
600mg taken orally twice daily (BID)
Drug: Alectinib
Oral capsule of alectinib
Other Names:
  • Alecensa
Experimental: Neladalkib (NVL-655)
150mg taken orally once daily (QD)
Drug: Neladalkib (NVL-655)
Oral tablet of Neladalkib (NVL-655)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) per blinded independent central review (BICR)
Time Frame: Up to 5 years after first patient dosed
Time from randomization to BICR-assessed radiographic disease progression or death
Up to 5 years after first patient dosed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 5 years after first patient dosed
Time from randomization to death
Up to 5 years after first patient dosed
Progression-free survival (PFS) per investigator assessment
Time Frame: Up to 5 years after first patient dosed
Time from randomization to investigator-assessed radiographic disease progression or death
Up to 5 years after first patient dosed
Time to intracranial progression per BICR
Time Frame: Up to 5 years after first patient dosed
Time from randomization to the first BICR-assessed occurrence of disease progression in the central nervous system (CNS)
Up to 5 years after first patient dosed
Intracranial objective response rate (IC-ORR)
Time Frame: Up to 5 years after first patient dosed
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
Up to 5 years after first patient dosed
Intracranial duration of response (IC-DOR)
Time Frame: Up to 5 years after first patient dosed
Time from first intracranial response (IC-CR or IC-PR) to radiographic intracranial disease progression or death
Up to 5 years after first patient dosed
Objective response rate (ORR)
Time Frame: Up to 5 years after first patient dosed
Proportion of patients with a complete response or partial response
Up to 5 years after first patient dosed
Duration of response (DOR)
Time Frame: Up to 5 years after first patient dosed
Time from first response (complete or partial) to radiographic disease progression or death
Up to 5 years after first patient dosed
Intracranial progression per investigator assessment
Time Frame: Up to 5 years after first patient dosed
Time to investigator-assessed intracranial progression
Up to 5 years after first patient dosed
Treatment-emergent adverse events (TEAEs) and changes in clinically relevant laboratory parameters
Time Frame: Up to 5 years after first patient dosed
Incidence and severity of TEAEs and changes in clinically relevant laboratory parameters
Up to 5 years after first patient dosed
Patient-reported measures in health-related quality of life (QoL)
Time Frame: Up to 5 years after first patient dosed
Changes in patient-reported outcomes (PROs) assessed by the European Organization for Research and Treatment of Cancer QoL core questionnaire - Cancer (EORTC QLQ-C30)
Up to 5 years after first patient dosed
Patient-reported measures in lung cancer symptoms and side effects of treatment
Time Frame: Up to 5 years after first patient dosed
Changes in PROs assessed by the European Organization for Research and Treatment of Cancer QoL - Lung Cancer module (EORTC QLQ-LC29)
Up to 5 years after first patient dosed
Patient-reported measures in patient functioning
Time Frame: Up to 5 years after first patient dosed
Changes in PROs assessed by the European Quality of Life (EuroQol) 5-dimension questionnaire (EQ-5D-5L)
Up to 5 years after first patient dosed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuvalent Inc.

Investigators

  • Study Director: Kelly Curtis, MD, Nuvalent Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

November 8, 2024

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVL-655-04
  • 2024-517553-26 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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