RecruitingPhase 3NCT06765109

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

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)

Sponsor

Nuvalent Inc.

Enrollment

450 participants

Start Date

Jul 17, 2025

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer Anaplastic Lymphoma Kinase-positive

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new targeted drug called neladalkib (NVL-655) as a first-line treatment for people with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called an ALK rearrangement. It will be compared head-to-head with an existing ALK-targeted drug, alectinib. **You may be eligible if...** - You have been diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC) - Your tumor has a confirmed ALK gene rearrangement (detected via tissue or blood test) - You have not yet received any systemic treatment for advanced NSCLC (prior adjuvant/neoadjuvant chemo is okay if finished more than 12 months ago) - You have at least one measurable tumor lesion - Your general health is good enough to participate **You may NOT be eligible if...** - Your cancer has another known genetic driver mutation besides ALK - You have previously taken any ALK-targeted drug (like alectinib, crizotinib, lorlatinib) in any setting - You are allergic to the study drug or its components Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeladalkib (NVL-655)

Oral tablet of Neladalkib (NVL-655)

DRUGAlectinib

Oral capsule of alectinib

Locations(137)

Palo Verde Hematology Oncology

Glendale, Arizona, United States

Hoag Hospital Newport Beach

Newport Beach, California, United States

University of California, Irvine Health

Orange, California, United States

Rocky Mountain Cancer Centers

Boulder, Colorado, United States

Sylvester Comprehensive Cancer Center Miami

Miami, Florida, United States

AdventHealth Cancer Institute

Orlando, Florida, United States

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University Center for Advanced Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Optum Medical Care, PC

Westbury, New York, United States

Duke Cancer Center

Durham, North Carolina, United States

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Sanatorio Parque S.A.

Rosario, Santa Fe Province, Argentina

Sanatorio Allende

Córdoba, Argentina

Westmead Hospital

Westmead, New South Wales, Australia

Austin Health

Heidelberg, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Wiener Gesundheitsverbund

Vienna, Austria

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Antwerp University Hospital

Edegem, Belgium

UZ Leuven

Leuven, Belgium

Fundação Pio XII

Barretos, Brazil

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, Brazil

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

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

Porto Alegre, Brazil

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

São José do Rio Preto, Brazil

A.C.Camargo Cancer Center

São Paulo, Brazil

Hospital Amaral Carvalho

São Paulo, Brazil

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Fundacion Arturo Lopez Perez FALP

Providencia, Chile

Centro de Investigaciones Clinicas UC CICUC

Santiago, Chile

Oncovida - Santiago

Santiago, Chile

Nemocnice AGEL Nový Jičín a.s.

Nový Jičín, Czechia

Aarhus Universitetshospital

Aarhus, Denmark

Herlev and Gentofte Hospital

Herlev, Denmark

University of Southern Denmark

Odense, Denmark

Centre Hospitalier Universitaire d' Angers

Angers, France

Institut Bergonie

Bordeaux, France

Centre Francois Baclesse

Caen, France

Centre Leon Berard

Lyon, France

Hospital Nord

Marseille, France

Institut Regional du Cancer de Montpellier

Montpellier, France

Centre Hospitalier Universitaire (CHU) Nantes Hopital Nord Laennec

Nantes, France

Centre Hospitalier Universitaire (CHU) de Bordeaux

Pessac, France

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, France

Helios Klinikum Emil von Behring GmbH

Berlin, Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, Germany

LungenClinic Grosshansdorf GmBH

Großhansdorf, Germany

Lungenfachklinik Immenhausen

Immenhausen, Germany

MVZ Onkologie Velbert

Velbert, Germany

Henry Dunant Hospital Center

Athens, Greece

Sotiria Thoracic Diseases Hospital of Athens

Athens, Greece

University General Hospital of Larissa

Larissa, Greece

Athens Medical Center

Marousi, Greece

Bioclinic Thessaloniki

Thessaloniki, Greece

Queen Mary Hospital Department of Medicine

Hong Kong, Hong Kong

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Prince of Wales Hospital

Shatin, Hong Kong

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

Debrecen, Hungary

Matrai Gyogyintezet

Gyöngyös, Hungary

Bacs-Kiskun Varmegyei Oktatokorhaz

Kecskemét, Hungary

Azienda Ospedaliero Universitaria delle Marche

Ancona, Italy

IRCCS Istituto Tumori Giovanni Paolo II

Bari, Italy

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

Meldola, Italy

Istituto Clinico Humanitas

Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

AUSL Della Romagna - Ospedale Santa Maria delle Croci

Ravenna, Italy

Istituti Fisioterapici Ospitalieri - IRCCS Istituto Nazionale Tumori Regina Elena

Roma, Italy

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

Torino, Italy

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Aichi Cancer Center

Chikusa, Japan

Shizuoka Cancer Center

Nagaizumi-chō, Japan

Okayama University Hospital

Okayama, Japan

Osaka International Cancer Institute

Osaka, Japan

Kindai University Hospital

Sakai, Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Tokyo, Japan

Wakayama Medical University Hospital

Wakayama, Japan

Kanagawa Cancer Center

Yokohama, Japan

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, Malaysia

Hospital Pulau Pinang

George Town, Pulau Pinang, Malaysia

Institut Kanser Negara

Putrajaya, Putrajaya, Malaysia

Beacon International Specialist Centre

Petaling Jaya, Selangor, Malaysia

Hospital Umum Sarawak

Kuching, Malaysia

Sunway Medical Centre

Subang Jaya, Malaysia

Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands

Radboud University Medical Center

Nijmegen, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands

Szpital Specjalistyczny w Brzozowie

Brzozów, Poland

Zanamed Medical Clinic Sp. z o.o.

Lublin, Poland

One Day Med

Szczecin, Poland

Hospital de Cascais

Alcabideche, Portugal

Fundacao Champalimaud

Lisbon, Portugal

CUF Porto Hospital

Porto, Portugal

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

Porto, Portugal

National Cancer Centre Singapore

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

Chungbuk National University Hospital

Cheongju-si, South Korea

Center for Lung Cancer, National Cancer Center

Goyang-si, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei Cancer Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Complejo Hospitalario Universitario a Coruña

A Coruña, Spain

ICO Badalona H.U. Germans Trias i Pujol

Badalona, Spain

UOMi Cancer Center

Barcelona, Spain

Hospital Universitari de Girona Dr Josep Trueta

Girona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chung Shan Medical University

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Phramongkutklao Hospital

Bangkok, Thailand

Ramathibodi Hospital, Mahidol University

Bangkok, Thailand

Siriraj Hospital Mahidol University

Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Rajavithi Hospital

Din Daeng, Thailand

HRH Princess Maha Chakri Sirindhorn Medical Center

Ongkharak, Thailand

Cambridge University Hospitals NHS Trust, Addenbrooke's Hospital

Cambridge, United Kingdom

Royal Free London NHS Foundation Trust

Hampstead, United Kingdom

Guy's Cancer Centre NHS Foundation Trust

London, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Maidstone Hospital

Maidstone, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06765109

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