Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
NCT ID: NCT06765109
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2025-07-17
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Neladalkib (NVL-655)
150mg taken orally once daily (QD)
Neladalkib (NVL-655)
Oral tablet of Neladalkib (NVL-655)
Alectinib
600mg taken orally twice daily (BID)
Alectinib
Oral capsule of alectinib
Interventions
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Neladalkib (NVL-655)
Oral tablet of Neladalkib (NVL-655)
Alectinib
Oral capsule of alectinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Nuvalent Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Viola Zhu, MD, PhD
Role: STUDY_DIRECTOR
Nuvalent Inc.
Locations
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Palo Verde Hematology Oncology
Glendale, Arizona, United States
University of California, Irvine Health
Orange, California, United States
Rocky Mountain Cancer Centers
Denver, 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
Clinical Research Alliance Inc.
New Hyde Park, New York, United States
Memorial Sloan Kettering Cancer Center
New York, 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
Westmead Hospital
Westmead, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Antwerp University Hospital
Edegem, , Belgium
UZ Leuven
Leuven, , Belgium
Nemocnice AGEL Nový Jičín a.s.
Nový Jičín, , Czechia
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
Klinikum Esslingen GmbH
Esslingen am Neckar, , Germany
LungenClinic Grosshansdorf GmBH
Großhansdorf, , Germany
Lungenfachklinik Immenhausen
Immenhausen, , 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
Matrai Gyogyintezet
Gyöngyös, , Hungary
Istituto Clinico Humanitas
Milan, , Italy
AUSL Della Romagna - Ospedale Santa Maria delle Croci
Ravenna, , Italy
Istituti Fisioterapici Ospitalieri - IRCCS Istituto Nazionale Tumori Regina Elena
Roma, , Italy
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, , 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
Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, , 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
UOMi Cancer Center
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , 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
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
Countries
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Central Contacts
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Other Identifiers
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NVL-655-04
Identifier Type: -
Identifier Source: org_study_id
2024-517553-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id