NCT05118789From ClinicalTrials.govRecruiting

A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors (ARROS-1)

Locally Advanced Solid Tumor
Metastatic Solid Tumor

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: Nuvalent Inc.
Enrolment target: 359
Started: 4 January 2022
Main results due: 31 December 2027
Study sites: 63
Registry updated: 24 September 2026

Can you take part?

Aged 12 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

1. Age ≥18 years (Cohort 2e only: Age ≥12 years).
2. Disease Criteria:

   1. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement.
   2. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement.
   3. Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement.
3. Prior anticancer treatment (except cohort 2a).
4. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1. Phase 2: Must have measurable disease according to RECIST 1.1.
5. Adequate baseline organ function and bone marrow reserve.

Exclusion Criteria:

1. Patient's cancer has a known oncogenic driver alteration other than ROS1.
2. Known allergy/hypersensitivity to excipients of NVL-520.
3. Major surgery within 4 weeks of first dose of study drug.
4. Ongoing anticancer therapy.
5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(63)

UCI Medical Center
Orange, California, United States
Recruiting
Stanford Medicine
Palo Alto, California, United States
Recruiting
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Recruiting
University of Colorado Cancer Center
Denver, Colorado, United States
Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Recruiting
University of Miami
Coral Gables, Florida, United States
Recruiting
University of Chicago
Chicago, Illinois, United States
Recruiting
Mass General Hospital
Boston, Massachusetts, United States
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Henry Ford Cancer Institute
Detroit, Michigan, United States
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
NYU Langone Health
New York, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States
Recruiting
Ohio State University
Columbus, Ohio, United States
Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Active, not recruiting
NEXT Oncology - Virginia Cancer Specialists
Fairfax, Virginia, United States
Recruiting
University of Washington / Fred Hutchinson Cancer Center
Seattle, Washington, United States
Recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Recruiting
University Hospital Leuven
Leuven, Belgium
Recruiting
Cross Cancer Institute
Edmonton, Alberta, Canada
Recruiting
Princess Margaret Cancer Research
Toronto, Ontario, Canada
Recruiting
Centre Legon Berard
Lyon, France
Recruiting
CHU de Nantes
Nantes, France
Recruiting
Claudius Regaud Institute
Toulouse, France
Recruiting
Institute Gustave Roussy
Villejuif, France
Recruiting
Cologne University Hospital
Cologne, Germany
Recruiting
Università Politecnica Marche
Ancona, Italy
Recruiting
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy
Completed
Istituto Europeo di Oncologia
Milan, Italy
Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Recruiting
Istituto Oncologico Veneto
Padova, Italy
Recruiting
Ospedale Santa Maria delle Croci
Ravenna, Italy
Recruiting
Istituto Nazionale Tumori Regina Elena
Rome, Italy
Recruiting
Kanagawa Cancer Center
Kanagawa, Japan
Recruiting
Okayama University Hospital
Okayama, Japan
Recruiting
Kindai University Hospital
Osaka, Japan
Recruiting
Shizuoka Cancer Center
Shizuoka, Japan
Completed
National Cancer Center Hospital
Tokyo, Japan
Recruiting
The Cancer Institute Hospital Of JFCR
Tokyo, Japan
Recruiting
Wakayama Medical University Hospital
Wakayama, Japan
Recruiting
Netherlands Cancer Institute
Amsterdam, Netherlands
Recruiting
University Medical Centre Groningen
Groningen, Netherlands
Recruiting
National University Hospital Singapore
Singapore, Singapore
Active, not recruiting
National Cancer Centre Singapore
Singapore, Singapore
Recruiting
National Cancer Center
Gyeonggi-do, South Korea
Recruiting
Seoul National University Hospital
Seoul, South Korea
Recruiting
Yonsei University Health System
Seoul, South Korea
Recruiting
Samsung Medical Center
Seoul, South Korea
Recruiting
University Hospital of A Coruña
A Coruña, Spain
Recruiting
UOMI Cancer Center - Clinica Tres Torres
Barcelona, Spain
Recruiting
Vall d'Hebron University Hospital
Barcelona, Spain
Recruiting
Gregorio Marañón Hospital
Madrid, Spain
Recruiting
Hospital Universitario 12 de Octubre
Madrid, Spain
Recruiting
Hospital Universitario HM Sanchinarro
Madrid, Spain
Recruiting
Chung Shan Medical University Hospital
Taichung, Taiwan
Recruiting
National Cheng Kung University Hospital
Tainan, Taiwan
Recruiting

Showing 60 of 63 sites — filter to narrow it down. 58 of the 63 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05118789. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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