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Taking people in TaiwanPhase 1/2

Testing zidesamtinib in people with advanced ROS1-positive lung and other solid tumors

Tests zidesamtinib in people, age 12 and older, with advanced ROS1-positive tumors.

Key facts

Who runs it
Nuvalent Inc.
Where
Taichung, Tainan, and Taipei, TaiwanSee the 3 sitesAlso in 13 other countries, 60 sites
Registry title
A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
Status
Recruiting
Phase
Phase 1/2
People taking part
359 people, planned
Started
4 Jan 2022
Expected to end
31 Dec 2028
Type of study
Interventional, 6 groups
Treatments tested
  • Zidesamtinib (NVL-520)
Record updated
24 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults and teenagers (from age 12 in one group) with advanced lung cancer or another advanced solid tumor that has a ROS1 rearrangement.

Age
18 years or older; 12 years or older for Cohort 2e only.
Sex
All sexes can join.
Disease stage
Locally advanced or metastatic solid tumor. Phase 2 cohorts 2a–2d need non-small cell lung cancer (NSCLC); cohort 2e needs a solid tumor other than NSCLC. Disease must be measurable (evaluable in Phase 1) by RECIST 1.1.
Earlier treatment
Prior anticancer treatment is required, except for cohort 2a.
Biomarker or test result
Documented ROS1 rearrangement.

Main reasons for not taking part

  • Cancer with a known driver gene change other than ROS1
  • Known allergy to an ingredient of NVL-520
  • Major surgery within 4 weeks of the first dose
  • Ongoing anticancer therapy
  • Receiving treatment in another clinical study

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Age ≥18 years (Cohort 2e only: Age ≥12 years)
  • Disease Criteria:; Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement; Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement; Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement
  • Prior anticancer treatment (except cohort 2a)
  • 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
  • Adequate baseline organ function and bone marrow reserve

Who cannot take part

  • Major surgery within 4 weeks of first dose of study drug
  • Ongoing anticancer therapy
  • Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study
  • Patient's cancer has a known oncogenic driver alteration other than ROS1
  • Known allergy/hypersensitivity to excipients of NVL-520

Where in Taiwan

Also in 13 other countries, 60 sites

  • Chung Shan Medical University HospitalTaichung, TaiwanContact: Gee Chen Chang, MD, PhD (principal investigator)Taking people
  • National Cheng Kung University HospitalTainan, TaiwanContact: Chien-Chung Lin, MD, PhD (principal investigator)Taking people
  • National Taiwan University HospitalTaipei, TaiwanContact: Chia-Chi Lin, MD, PhD (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 6 groups in the trial

  • Phase 1 dose escalationTreatment being tested

    Zidesamtinib (NVL-520) oral daily dosing

    Treatment: Zidesamtinib (NVL-520)

  • Cohort 2aTreatment being tested

    ROS1+ NSCLC naïve to TKI therapy and up to 1 prior chemotherapy and/or immunotherapy

    Treatment: Zidesamtinib (NVL-520)

  • Cohort 2bTreatment being tested

    ROS1+ NSCLC treated with 1 prior ROS1 TKI and no prior chemotherapy or immunotherapy

    Treatment: Zidesamtinib (NVL-520)

  • Cohort 2cTreatment being tested

    ROS1+ NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy

    Treatment: Zidesamtinib (NVL-520)

  • Cohort 2dTreatment being tested

    ROS1+ NSCLC treated with ≥2 prior ROS1 TKIs and up to 1 prior chemotherapy and/or immunotherapy

    Treatment: Zidesamtinib (NVL-520)

  • Cohort 2eTreatment being tested

    ROS1+ solid tumor and progressed on any prior therapy

    Treatment: Zidesamtinib (NVL-520)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Testing zidesamtinib in people with advanced ROS1-positive lung and other solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
24 September 2026