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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230693

Enrollment

Registered

2024-03-12

Start date

2024-04-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced NSCLC and Other Solid Tumors

Interventions

IMP: Zidesamtinib (NVL-520) Zidesamtinib (NVL-520) is a tablet taken by mouth. Patients will receive study drug continuously from first dose until disease progression, unacceptable toxicity, withdrawa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >=18 years (Cohort 2e only: Age >=12 years). 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. 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. Prior therapy requirements Cohort 2a: ROS1-positive NSCLC naive to Tyrosine Kinase Inhibitor (TKI) therapy and up to 1 prior chemotherapy and/or immunotherapy. Cohort 2b: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and no prior chemotherapy or immunotherapy. Cohort 2c: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy. Cohot 2d: ROS1-positive NSCLC treated with >=2 prior ROS1 TKIs and up to 1 prior chemotherapy and/or immunotherapy. Cohort 2e: ROS1-positive solid tumor and progressed on any prior therapy.

Exclusion criteria

Exclusion criteria: Patient's cancer has a known oncogenic driver alteration other than ROS1. Known allergy/hypersensitivity to excipients of NVL-520. 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.

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose (Phase 1): Highest dose with dose-limiting toxicity (DLT) rate =< 25% RP2D: To determine the RP2D Objective Response Rate (ORR) (Phase 2): To determine ORR as assessed by BICR	—

Countries

Australia, Belgium, Canada, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Taiwan, UK, USA

Contacts

Public ContactKazushige Takai

A2 Healthcare Corporation

NVL-520_trialinfomation@a2healthcare.com+81-3-3830-1756

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026