N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Nuvalent Inc. • ClinicalTrials.gov ID: NCT06765109

Registry updated: 2026-09-30
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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).

Interventions

  • Neladalkib (NVL-655) (Drug)
    Oral tablet of Neladalkib (NVL-655)
  • Alectinib (Drug)
    Oral capsule of alectinib

Eligibility criteria

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

Conditions

Non-small Cell Lung Cancer Anaplastic Lymphoma Kinase-positive

Locations

  • 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
  • NYU Langone's Perlmutter Cancer Center — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Optum Medical Care, PC — Westbury, New York, United States
  • Carolinas Medical Center — Charlotte, North Carolina, 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
  • Alliance Cancer Specialists — Sellersville, Pennsylvania, United States
  • SCRI Oncology Partners — Nashville, Tennessee, United States
  • Virginia Cancer Specialists — Fairfax, Virginia, United States
  • University of Washington - Fred Hutchinson Cancer Center — Seattle, Washington, United States
  • Compass Oncology — Vancouver, Washington, United States
  • Sanatorio Parque S.A. — Rosario, Santa Fe Province, Argentina
  • Sanatorio Allende — Córdoba, Argentina
  • Centro Médico Privado CEMIC — 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
  • Instituto do Cancer do Estado de São Paulo ICESP — São Paulo, 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 Oncologia de Precision de la Universidad Mayor — Santiago, 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
  • APHP - Hôpital Tenon — Paris, 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
  • GENESIS General Clinic — 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
  • Bekes Varmegyei Kozponti Korhaz — Gyula, 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
  • Fondazione IRCCS San Gerardo dei Tintori — Monza, 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
  • ASL Taranto Ospedale S. G. Moscati — Statte, 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
  • National Cancer Center Hospital — Tokyo, 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
  • Health Pharma Professional Research S.A de C.V. — Mexico City, Mexico
  • Centro Oncológico Personalizado — Mexico City, Mexico
  • Instituto Nacional de Cancerologia — Mexico City, Mexico
  • Hospital Universitario Dr. Jose Eleuterio González — Monterrey, Mexico
  • Centro de Investigacion Clinica Chapultepec S.A. de C.V. — Morelia, Mexico
  • Oncologia Integral Satelite S. A. de C. V. — Naucalpan, Mexico
  • 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
  • Uniwersyteckie Centrum Kliniczne — Gdansk, 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
  • Luzerner Kantonsspital — Lucerne, Switzerland
  • 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 Surrey County Hospital — Guildford, 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
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record