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

NCT ID NCT06765109

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 26, 2026 · Updated 7 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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Get notified about this study

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    157 sites in 29 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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 Nacional de Cancerologia

    RECRUITING

    Mexico City, 14080, Mexico

  • 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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