Actively Recruiting
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Led by Nuvalent Inc. · Updated on 2025-10-30
840
Participants Needed
74
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of neladalkib (NVL-655), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will evaluate the overall safety and tolerability of neladalkib and will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of neladalkib in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of neladalkib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of neladalkib in patients with advanced ALK-positive NSCLC and other solid tumors.
CONDITIONS
Official Title
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older; for Phase 2 Cohort 2f, age 12 years or older and weighing more than 40 kg
- Phase 1: Confirmed locally advanced or metastatic solid tumor with ALK rearrangement or activating ALK mutation
- Phase 2 Cohorts except 2f: Confirmed locally advanced or metastatic NSCLC with ALK rearrangement
- Phase 2 Cohort 2f: Confirmed locally advanced or metastatic solid tumor with ALK rearrangement or activating ALK mutation detected by certified assay
- Phase 1: Must have evaluable disease per RECIST 1.1
- Phase 2: Must have measurable disease per RECIST 1.1
- Adequate organ function and bone marrow reserve
You will not qualify if you...
- Cancer with oncogenic driver alteration other than ALK
- Known allergy or hypersensitivity to neladalkib (NVL-655) excipients
- Major surgery within 4 weeks before study entry
- Ongoing anticancer therapy
- Actively receiving systemic treatment or medical intervention in another therapeutic clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 74 locations
1
University of California Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
2
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
3
Stanford Cancer Institute
Stanford, California, United States, 94305
Actively Recruiting
4
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
6
University of Miami; Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
7
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
9
John Hopkins University
Baltimore, Maryland, United States, 21224
Actively Recruiting
10
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
11
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
Henry Ford Cancer Institute
Detroit, Michigan, United States, 48202
Actively Recruiting
13
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States, 63310
Actively Recruiting
14
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
15
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
16
Duke University Medical Center
Durham, North Carolina, United States, 27705
Actively Recruiting
17
OSU Brain & Spine Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
18
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
19
Sarah Cannon
Nashville, Tennessee, United States, 37203
Actively Recruiting
20
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Active, Not Recruiting
21
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
22
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Actively Recruiting
23
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
24
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
25
Universitair Ziekenhuis Antwerpen (UZA)
Antwerp, Belgium, 2650
Actively Recruiting
26
Universitaire Ziekenhuizen Leuven Campus Gastthuisberg
Leuven, Belgium, 3000
Actively Recruiting
27
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
28
BC Cancer Center
Vancouver, British Columbia, Canada, VZ 4E6
Actively Recruiting
29
The Ottawa Hospital Cancer Center
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
30
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 0A3
Actively Recruiting
31
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
32
Chu De Nantes
Nantes, France, 44093
Actively Recruiting
33
Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
34
Institute Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
35
Universitatsklinikum Koln - University Hospital Cologne
Cologne, Germany, 50937
Actively Recruiting
36
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Actively Recruiting
37
LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany, 22927
Actively Recruiting
38
Universkitatsklinikum Heidelberg - University Hospital Heidelberg
Heidelberg, Germany, 69126
Actively Recruiting
39
Azienda Ospedaliera Universitaria Ospedali Riuniti Umberto
Ancona, Italy, 60126
Actively Recruiting
40
IRCCS Istituto Tumori "G. Paolo II"
Bari, Italy, 70124
Actively Recruiting
41
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
42
Instituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
43
Instituto Oncologico Veneto
Padova, Italy, 35128
Actively Recruiting
44
Ospedale Santa Maria delle Croci
Ravenna, Italy, 48100
Actively Recruiting
45
Regina Elena Institute for Cancer Research
Rome, Italy, 00144
Actively Recruiting
46
Kanagawa Cancer Center
Kanagawa, Japan, 2418515
Actively Recruiting
47
Okayama University Hospital
Okayama, Japan, 7008558
Actively Recruiting
48
Kindai University Hospital
Osaka, Japan, 5898511
Actively Recruiting
49
Shizuoka Cancer Center
Shizuoka, Japan, 4118777
Actively Recruiting
50
National Cancer Center Hospital
Tokyo, Japan, 1040051
Actively Recruiting
51
Cancer Institute Hospital of JFCR
Tokyo, Japan, 1358550
Actively Recruiting
52
Wakayama Medical University Hospital
Wakayama, Japan, 6418510
Actively Recruiting
53
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
54
University Medical Center Groningen (UMCG)
Groningen, Netherlands, 9713 GZ
Actively Recruiting
55
National University Hospital
Singapore, Singapore, Singapore, 119074
Actively Recruiting
56
National Cancer Centre Singapore
Singapore, Singapore, Singapore, 168583
Actively Recruiting
57
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 10408
Actively Recruiting
58
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
59
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
60
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
61
Complejo Hospitalario Universitario de A Coruna
A Coruña, Spain, 15006
Actively Recruiting
62
UOMI Cancer Center
Barcelona, Spain, 08017
Actively Recruiting
63
Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
64
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28009
Actively Recruiting
65
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
66
Istituto Oncologico Svizzera Italiana
Bellinzona, Switzerland, 6500
Actively Recruiting
67
Luzerner Kantonsspital
Lucerne, Switzerland, 6000
Actively Recruiting
68
Chung-Shan Medical University Hospital
Taichung, Taiwan, 402306
Actively Recruiting
69
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
70
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
71
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
72
Edinburgh Cancer Centre
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
73
The Royal Marsden - Chelsea
London, United Kingdom, SM2 5PT
Actively Recruiting
74
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
N
Nuvalent Clinical Trial
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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