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Contact Information:

Nuvalent 857-357-7000
clinicaltrials@nuvalent.com


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

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

Recruiting

Open to: ALL

Age: 12.0 - N/A

Medical Conditions

Neoplasms


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jan 2022 Oct 2025

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Oral tablet of zidesamtinib (NVL-520)

Intervention Arm Group : Cohort 2a;Cohort 2b;Cohort 2c;Cohort 2d;Cohort 2e;Phase 1 dose escalation;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Marsden Hospital
    London
    SW3 6JJ
  • Christie NHS Foundation Trust
    Manchester
    M20 4BX


The study is sponsored by Nuvalent Inc.




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Read full details for Trial ID: NCT05118789
Last updated 30 July 2025

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