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Evaluating NVL-520 for Advanced ROS1-positive Solid Tumors

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)

Phase1; Phase2 Interventional Nuvalent Inc. · NCT05118789

This study is testing a new drug called NVL-520 to see if it can safely help people with advanced solid tumors that have a specific genetic change called ROS1.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment359 (estimated)
Ages12 Years and up
SexAll
SponsorNuvalent Inc. Industry-sponsored
Drugs / interventionszidesamtinib, chemotherapy, immunotherapy
Locations63 sites (Orange, California and 62 other locations)
Trial IDNCT05118789 on ClinicalTrials.gov

What this trial studies

This clinical trial is a Phase 1/2 study designed to assess the safety, tolerability, and antitumor activity of NVL-520 in patients with advanced solid tumors that have a ROS1 rearrangement. The trial will begin with a dose escalation phase to determine the recommended phase 2 dose and maximum tolerated dose of NVL-520. Following this, the Phase 2 portion will evaluate the objective response rate and other efficacy measures in various cohorts of patients with ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors. The study aims to provide insights into the effectiveness of NVL-520 in treating these specific cancer types.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced ROS1-positive NSCLC or other solid tumors who have specific treatment histories.

Not a fit: Patients with cancers that have known oncogenic driver alterations other than ROS1 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced ROS1-positive solid tumors.

How similar studies have performed: Other studies targeting ROS1 rearrangements have shown promise, indicating that this approach is supported by prior research.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Orange, California and 62 other locations

+13 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Locally Advanced Solid TumorMetastatic Solid Tumor
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.