Testing zidesamtinib in people with advanced ROS1-positive lung and other solid tumors
Tests zidesamtinib in people, age 12 and older, with advanced ROS1-positive tumors.
Plain-language title generated from the registry record
Registry title: A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
Key facts
- Where
- Gyeonggi-do and Seoul, South KoreaSee the 4 sites
- Phase
- Phase 1/2
Where in South Korea
- National Cancer CenterGyeonggi-do, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Yonsei University Health SystemSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nuvalent Inc.
- Trial code
- NCT05118789EU 2024-511793-71-00
- Record updated
- 24 September 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: Age ≥18 years (Cohort 2e only: Age ≥12 years); Disease Criteria:; Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement; Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement; Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement; Prior anticancer treatment (except cohort 2a); 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; Adequate baseline organ function and bone marrow reserve.
Exclusion: Major surgery within 4 weeks of first dose of study drug; Ongoing anticancer therapy; Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study; Patient's cancer has a known oncogenic driver alteration other than ROS1; Known allergy/hypersensitivity to excipients of NVL-520.