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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Zidesamtinib (NVL-520) (drug)
How long the study runs: Study runs about 83 months (dates as stated)
About the drug or intervention: Zidesamtinib (NVL-520) — drug: Oral tablet of zidesamtinib (NVL-520)
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 12 Years and over
Who: All
Number of participants: 359
Started: 2022-01-04
Last checked: 2026-09

Plain English Summary

What is this study?

• Testing a new treatment for locally advanced solid tumor
• Phase1/Phase2 - 359 participants
• 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

Who can take part?

• Ages 12 Years and over
• Diagnosed with locally advanced solid tumor

Where?

• London - Royal Marsden Hospital
• Manchester - Christie NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

In Phase 2, study patients 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.

Locally Advanced Solid TumorMetastatic Solid Tumor

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 12 Years and over
Who can join: All genders

Biomarkers mentioned

ROS1

Treatment history

Treatments you must have had:

✓ evaluable disease (target or nontarget) according to RECIST 1

What the study is looking for

✓Age ≥18 years (Cohort 2e only: Age ≥12 years).
✓Disease Criteria:
✓Phase 1: confirmed by testing a sample that has grown locally or that has spread solid tumor with documented ROS1...
✓Phase 2: Cohorts 2a, 2b, 2c and 2d: confirmed by testing a sample that has grown locally or that has spread NSCLC...
✓Phase 2: Cohort 2e: confirmed by testing a sample that has grown locally or that has spread solid tumor (other than...

Who cannot take part

✗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 the study treatment.
✗Ongoing anticancer therapy.
✗Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.

See the full 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 Is This Study? (2 UK sites)

Royal Marsden Hospital

London SW3 6JJ, United Kingdom

Recruiting

Site contact (verified)

Sanjay Popat, MBBS, PhDPrincipal Investigator

Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

COMPLETED

Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net ---

How to Get in Touch

Nuvalent

Sponsor contact

CONTACT

857-357-7000 clinicaltrials@nuvalent.com

Data sourced from ClinicalTrials.gov · Last verified: 2026-09