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RecruitingLast updated: 16 February 2026

AROS-1: This study is seeking to determine the best dose level, safety and effectiveness of a new cancer drug (NVL-250) in people with locally advanced solid cancersA Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors (ARROS-1)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People12+

Trial acronym

AROS-1

Clinical summary

Summary

This study has two parts.

Phase 1 will determine the recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of NVL-520 in people with advanced ROS1-positive solid cancers. In this phase, NVL-520 will be given orally, daily.

Phase 2 will further evaluate how safe, tolerable and effective NVL-520 is in people with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid cancers.

In Phase 2, participants will be enrolled into 5 distinct expansion cohorts:

  • Cohort 2a: ROS1-positive NSCLC naïve 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.
  • Cohort 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.

Conditions

This trial is treating people with ROS1-positive non-small cell lung cancer and other advanced ROS1-positive solid cancers

Eligibility

Inclusion

  1. Age ≥18 years (Cohort 2e only: Age ≥12 years and weighing>40 kg).

  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

  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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You are able to swallow medication by mouth.

Exclusion

  • You are currently being treated on a clinical trial.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Nuvalent Inc.

Scientific Title

A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors (ARROS-1)

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