Actively Recruiting
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Led by Nuvalent Inc. · Updated on 2026-05-14
450
Participants Needed
153
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)
- Documented ALK rearrangement via tissue or blood testing
- No prior systemic anticancer treatment for NSCLC (adjuvant/neoadjuvant chemotherapy allowed if completed 12 months before randomization; no prior ALK TKI treatment)
- Measurable disease with one or more target lesions per RECIST 1.1
- Availability of pretreatment tumor tissue
You will not qualify if you...
- Cancer with known oncogenic driver alteration other than ALK
- Known allergy or hypersensitivity to excipients of neladalkib or alectinib
- Ongoing or recent radiotherapy within protocol-specified timeframes before randomization
- Major surgery within 4 weeks before randomization
- Uncontrolled clinically relevant infection requiring systemic therapy
- Known active tuberculosis or active Hepatitis B or C
- QTcF greater than 470 msec on repeated assessments
- Clinically significant cardiovascular disease
- Brain metastases with progressive neurological symptoms or requiring increasing corticosteroids to control CNS disease
- Active malignancy requiring therapy within 2 years before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 153 locations
1
Palo Verde Hematology Oncology
Glendale, Arizona, United States, 85304
Actively Recruiting
2
Hoag Hospital Newport Beach
Newport Beach, California, United States, 92663
Actively Recruiting
3
University of California, Irvine Health
Orange, California, United States, 92868
Actively Recruiting
4
Rocky Mountain Cancer Centers
Boulder, Colorado, United States, 80218
Actively Recruiting
5
Sylvester Comprehensive Cancer Center Miami
Miami, Florida, United States, 33136
Actively Recruiting
6
AdventHealth Cancer Institute
Orlando, Florida, United States, 32804
Actively Recruiting
7
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Actively Recruiting
8
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Withdrawn
11
Washington University Center for Advanced Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
12
NYU Langone's Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
13
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
14
Optum Medical Care, PC
Westbury, New York, United States, 11590
Actively Recruiting
15
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Actively Recruiting
16
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
17
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
18
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
19
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
20
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
21
University of Washington - Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
22
Sanatorio Parque S.A.
Rosario, Santa Fe Province, Argentina, S20000DSV
Actively Recruiting
23
Sanatorio Allende
Córdoba, Argentina, 5000
Actively Recruiting
24
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
25
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
26
Peter MacCallum Cancer Centre
Melbourne, Australia, 3000
Actively Recruiting
27
Wiener Gesundheitsverbund
Vienna, Austria, 1210
Actively Recruiting
28
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
29
Antwerp University Hospital
Edegem, Belgium, 2650
Actively Recruiting
30
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
31
Fundação Pio XII
Barretos, Brazil, 14784
Actively Recruiting
32
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Brazil, 30150
Actively Recruiting
33
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil, 90035
Actively Recruiting
34
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul
Porto Alegre, Brazil, 90610
Actively Recruiting
35
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base
São José do Rio Preto, Brazil, 15090
Actively Recruiting
36
Instituto do Cancer do Estado de São Paulo ICESP
São Paulo, Brazil, 01246-000
Actively Recruiting
37
A.C.Camargo Cancer Center
São Paulo, Brazil, 01509-010
Actively Recruiting
38
Hospital Amaral Carvalho
São Paulo, Brazil, 17210-080
Actively Recruiting
39
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1L7
Actively Recruiting
40
Fundacion Arturo Lopez Perez FALP
Providencia, Chile, 7500000
Actively Recruiting
41
Centro de Oncologia de Precision de la Universidad Mayor
Santiago, Chile, 5750
Actively Recruiting
42
Centro de Investigaciones Clinicas UC CICUC
Santiago, Chile, 8320000
Actively Recruiting
43
Oncovida - Santiago
Santiago, Chile, 8320000
Actively Recruiting
44
Nemocnice AGEL Nový Jičín a.s.
Nový Jičín, Czechia, 74101
Actively Recruiting
45
Aarhus Universitetshospital
Aarhus, Denmark, 8200
Actively Recruiting
46
Herlev and Gentofte Hospital
Herlev, Denmark, 02730
Actively Recruiting
47
University of Southern Denmark
Odense, Denmark, 5000
Actively Recruiting
48
Centre Hospitalier Universitaire d' Angers
Angers, France, 49000
Actively Recruiting
49
Institut Bergonie
Bordeaux, France, 33000
Actively Recruiting
50
Centre Francois Baclesse
Caen, France, 14076
Actively Recruiting
51
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
52
Hospital Nord
Marseille, France, 13015
Actively Recruiting
53
Institut Regional du Cancer de Montpellier
Montpellier, France, 34298
Actively Recruiting
54
Centre Hospitalier Universitaire (CHU) Nantes Hopital Nord Laennec
Nantes, France, 44093
Actively Recruiting
55
APHP - Hôpital Tenon
Paris, France, 75020
Actively Recruiting
56
Centre Hospitalier Universitaire (CHU) de Bordeaux
Pessac, France, 33604
Actively Recruiting
57
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, France, 31059
Actively Recruiting
58
Helios Klinikum Emil von Behring GmbH
Berlin, Germany, 14165
Actively Recruiting
59
Klinikum Esslingen GmbH
Esslingen am Neckar, Germany, 73730
Actively Recruiting
60
LungenClinic Grosshansdorf GmBH
Großhansdorf, Germany, D-22927
Actively Recruiting
61
Lungenfachklinik Immenhausen
Immenhausen, Germany, 34376
Actively Recruiting
62
MVZ Onkologie Velbert
Velbert, Germany, 42551
Actively Recruiting
63
Henry Dunant Hospital Center
Athens, Greece, 115 26
Actively Recruiting
64
Sotiria Thoracic Diseases Hospital of Athens
Athens, Greece, 115 27
Actively Recruiting
65
University General Hospital of Larissa
Larissa, Greece, 411 10
Actively Recruiting
66
Athens Medical Center
Marousi, Greece, 151 25
Actively Recruiting
67
GENESIS General Clinic
Thessaloniki, Greece, 555 35
Actively Recruiting
68
Queen Mary Hospital Department of Medicine
Hong Kong, Hong Kong, 999077
Actively Recruiting
69
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Actively Recruiting
70
Prince of Wales Hospital
Shatin, Hong Kong
Actively Recruiting
71
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen, Hungary, 4032
Actively Recruiting
72
Matrai Gyogyintezet
Gyöngyös, Hungary, 7151
Actively Recruiting
73
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét, Hungary, 6000
Actively Recruiting
74
Azienda Ospedaliero Universitaria delle Marche
Ancona, Italy, 60126
Actively Recruiting
75
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124
Actively Recruiting
76
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, Italy, 47014
Actively Recruiting
77
Istituto Clinico Humanitas
Milan, Italy, 20089
Actively Recruiting
78
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
79
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
80
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, 20900
Actively Recruiting
81
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
82
AUSL Della Romagna - Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Actively Recruiting
83
Istituti Fisioterapici Ospitalieri - IRCCS Istituto Nazionale Tumori Regina Elena
Roma, Italy, 00144
Actively Recruiting
84
ASL Taranto Ospedale S. G. Moscati
Statte, Italy, 74010
Actively Recruiting
85
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Torino, Italy, 10060
Actively Recruiting
86
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
87
Aichi Cancer Center
Chikusa, Japan, 464-8681
Actively Recruiting
88
Shizuoka Cancer Center
Nagaizumi-chō, Japan, 411-0934
Actively Recruiting
89
Okayama University Hospital
Okayama, Japan, 700-8558
Actively Recruiting
90
Osaka International Cancer Institute
Osaka, Japan, 541-8567
Actively Recruiting
91
Kindai University Hospital
Sakai, Japan, 590-0197
Actively Recruiting
92
National Cancer Center Hospital
Tokyo, Japan, 1040045
Actively Recruiting
93
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, Japan, 135-8550
Actively Recruiting
94
Wakayama Medical University Hospital
Wakayama, Japan, 641-0012
Actively Recruiting
95
Kanagawa Cancer Center
Yokohama, Japan, 241-8515
Actively Recruiting
96
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
Actively Recruiting
97
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia, 10450
Actively Recruiting
98
Institut Kanser Negara
Putrajaya, Putrajaya, Malaysia, 62250
Actively Recruiting
99
Beacon International Specialist Centre
Petaling Jaya, Selangor, Malaysia, 46050
Actively Recruiting
100
Hospital Umum Sarawak
Kuching, Malaysia, 93586
Actively Recruiting
101
Sunway Medical Centre
Subang Jaya, Malaysia, 47500
Actively Recruiting
102
Health Pharma Professional Research S.A de C.V.
Mexico City, Mexico, 03100
Actively Recruiting
103
Centro Oncológico Personalizado
Mexico City, Mexico, 06760
Actively Recruiting
104
Hospital Universitario Dr. Jose Eleuterio González
Monterrey, Mexico, 64660
Actively Recruiting
105
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
Morelia, Mexico, 58260
Actively Recruiting
106
Oncologia Integral Satelite S. A. de C. V.
Naucalpan, Mexico, 53100
Actively Recruiting
107
Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
108
Radboud University Medical Center
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
109
University Medical Center Utrecht
Utrecht, Netherlands, 3584
Actively Recruiting
110
Szpital Specjalistyczny w Brzozowie
Brzozów, Poland, 36-200
Actively Recruiting
111
Zanamed Medical Clinic Sp. z o.o.
Lublin, Poland, 20-601
Actively Recruiting
112
One Day Med
Szczecin, Poland, 70-419
Actively Recruiting
113
Hospital de Cascais
Alcabideche, Portugal, 2755-009
Actively Recruiting
114
Fundacao Champalimaud
Lisbon, Portugal, 1400-038
Actively Recruiting
115
CUF Porto Hospital
Porto, Portugal, 4100-180
Actively Recruiting
116
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, Portugal, 4200-072
Actively Recruiting
117
National Cancer Centre Singapore
Singapore, Singapore, 168583
Actively Recruiting
118
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Actively Recruiting
119
Chungbuk National University Hospital
Cheongju-si, South Korea, 28644
Actively Recruiting
120
Center for Lung Cancer, National Cancer Center
Goyang-si, South Korea, 10408
Actively Recruiting
121
Gachon University Gil Medical Center
Incheon, South Korea, 21565
Actively Recruiting
122
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
123
Severance Hospital Yonsei Cancer Center
Seoul, South Korea, 03722
Actively Recruiting
124
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
125
Complejo Hospitalario Universitario a Coruña
A Coruña, Spain, 15006
Actively Recruiting
126
ICO Badalona H.U. Germans Trias i Pujol
Badalona, Spain, 08916
Actively Recruiting
127
UOMi Cancer Center
Barcelona, Spain, 08017
Actively Recruiting
128
Hospital Universitari de Girona Dr Josep Trueta
Girona, Spain, 17007
Actively Recruiting
129
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
130
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
131
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
132
Hospital Regional Universitario de Malaga
Málaga, Spain, 29010
Actively Recruiting
133
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
134
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
135
Luzerner Kantonsspital
Lucerne, Switzerland, 6004
Actively Recruiting
136
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
137
Chung Shan Medical University
Taichung, Taiwan, 40201
Actively Recruiting
138
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
139
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
140
Phramongkutklao Hospital
Bangkok, Thailand, 10400
Actively Recruiting
141
Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Actively Recruiting
142
Siriraj Hospital Mahidol University
Bangkok, Thailand, 10700
Actively Recruiting
143
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand, 50200
Actively Recruiting
144
Rajavithi Hospital
Din Daeng, Thailand, 10400
Actively Recruiting
145
HRH Princess Maha Chakri Sirindhorn Medical Center
Ongkharak, Thailand, 26120
Actively Recruiting
146
Cambridge University Hospitals NHS Trust, Addenbrooke's Hospital
Cambridge, United Kingdom, NG5 1PB
Actively Recruiting
147
Royal Surrey County Hospital
Guildford, United Kingdom, GU2 7XX
Actively Recruiting
148
Royal Free London NHS Foundation Trust
Hampstead, United Kingdom, NW3 2QG
Actively Recruiting
149
Guy's Cancer Centre NHS Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
150
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
151
Maidstone Hospital
Maidstone, United Kingdom, ME16 9QQ
Actively Recruiting
152
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
153
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
Research Team
N
Nuvalent Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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