Actively Recruiting
A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
Led by Nuvalent Inc. · Updated on 2025-10-24
359
Participants Needed
63
Research Sites
364 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 zidesamtinib (NVL-520), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors. Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of zidesamtinib in patients with advanced ROS1-positive solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of zidesamtinib 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 zidesamtinib in patients with advanced ROS1-positive NSCLC and other solid tumors.
CONDITIONS
Official Title
A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (except cohort 2e which allows 12 years or older)
- Phase 1: Confirmed locally advanced or metastatic solid tumor with ROS1 rearrangement
- Phase 2 cohorts 2a to 2d: Confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement
- Phase 2 cohort 2e: Confirmed locally advanced or metastatic solid tumor other than NSCLC with ROS1 rearrangement
- Prior anticancer treatment allowed except for cohort 2a
- Phase 1: Must have evaluable disease according to RECIST 1.1
- Phase 2: Must have measurable disease according to RECIST 1.1
- Adequate baseline organ function and bone marrow reserve
You will not qualify if you...
- Cancer with known driver alterations other than ROS1
- Allergy or hypersensitivity to NVL-520 or its excipients
- Major surgery within 4 weeks before first dose
- Ongoing anticancer therapy
- Currently receiving systemic treatment or medical intervention in another clinical trial
AI-Screening
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Trial Site Locations
Total: 63 locations
1
UCI Medical Center
Orange, California, United States, 92868
Actively Recruiting
2
Stanford Medicine
Palo Alto, California, United States, 94305
Actively Recruiting
3
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
4
University of Colorado Cancer Center
Denver, 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
Coral Gables, Florida, United States, 33146
Actively Recruiting
7
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
8
Mass General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Henry Ford Cancer Institute
Detroit, Michigan, United States, 48202
Actively Recruiting
11
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
12
NYU Langone Health
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
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
15
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
16
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
17
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
18
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Active, Not Recruiting
19
NEXT Oncology - Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
20
University of Washington / Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
21
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
22
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
23
University Hospital Leuven
Leuven, Belgium, 3000
Actively Recruiting
24
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
25
Princess Margaret Cancer Research
Toronto, Ontario, Canada, M5GG 1L7
Actively Recruiting
26
Centre Legon Berard
Lyon, France, 69008
Actively Recruiting
27
CHU de Nantes
Nantes, France, 44000
Actively Recruiting
28
Claudius Regaud Institute
Toulouse, France, 31300
Actively Recruiting
29
Institute Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
30
Cologne University Hospital
Cologne, Germany
Actively Recruiting
31
Università Politecnica Marche
Ancona, Italy, 60121
Actively Recruiting
32
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124
Actively Recruiting
33
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
34
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
35
Istituto Oncologico Veneto
Padova, Italy, 35128
Actively Recruiting
36
Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Actively Recruiting
37
Istituto Nazionale Tumori Regina Elena
Rome, Italy, 00128
Actively Recruiting
38
Kanagawa Cancer Center
Kanagawa, Japan, 241-8515
Actively Recruiting
39
Okayama University Hospital
Okayama, Japan, 700-8558
Actively Recruiting
40
Kindai University Hospital
Osaka, Japan, 577-8502
Actively Recruiting
41
Shizuoka Cancer Center
Shizuoka, Japan, 411-8777
Actively Recruiting
42
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Actively Recruiting
43
The Cancer Institute Hospital Of JFCR
Tokyo, Japan, 135-8550
Actively Recruiting
44
Wakayama Medical University Hospital
Wakayama, Japan, 641-8510
Actively Recruiting
45
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066
Actively Recruiting
46
University Medical Centre Groningen
Groningen, Netherlands
Actively Recruiting
47
National University Hospital Singapore
Singapore, Singapore, 119074
Actively Recruiting
48
National Cancer Centre Singapore
Singapore, Singapore, 168583
Actively Recruiting
49
National Cancer Center
Gyeonggi-do, South Korea, 10408
Actively Recruiting
50
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
51
Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
52
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
53
University Hospital of A Coruña
A Coruña, Spain, 15006
Actively Recruiting
54
UOMI Cancer Center - Clinica Tres Torres
Barcelona, Spain, 08017
Actively Recruiting
55
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Actively Recruiting
56
Gregorio Marañón Hospital
Madrid, Spain, 28007
Actively Recruiting
57
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
58
Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
59
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
Actively Recruiting
60
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
61
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
62
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Actively Recruiting
63
Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
N
Nuvalent
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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