A Study of Zidesamtinib (NVL-520) for ROS1-Positive Cancers
This study is testing a drug called zidesamtinib (NVL-520) in people with advanced solid tumors, including non-small cell lung cancer (NSCLC), that have a specific genetic change called a ROS1 rearrangement. Zidesamtinib is a type of kinase inhibitor. The study aims to find the safest and most effective dose of zidesamtinib and see how well it shrinks tumors. To join, you must have a ROS1 rearrangement in your tumor. The study is looking for about 359 participants aged 12 and older. The study's success will be measured by how many patients experience their tumors shrinking or disappearing (Objective Response Rate). The current status of the study is unclear.
- Study design
- This is a Phase 1/2 study, meaning it will first find the right dose and then test its effectiveness. It is designed to enroll approximately 359 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Objective Response Rate will be measured 2-3 years after the first patient is dosed in Phase 2.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
At a glance
Conditions
Where it's being run
63 sites across 31 statesStudy leadership
- Vivek Upadhyay, MD, MBI · STUDY_DIRECTOR · Nuvalent Inc.
Who to contact
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What this trial measures
- Maximum Tolerated Dose (MTD) (Phase 1)Within 28 days of last patient dosed during dose escalation
Highest dose with dose-limiting toxicity (DLT) rate ≤ 25%
- Recommended Phase 2 Dose (RP2D)Within 28 days of last patient dosed during dose escalation.
To determine the RP2D
- Objective Response Rate (ORR) (Phase 2)2-3 years after first patient dosed.
To determine ORR as assessed by BICR