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

Part of paid clinical trials in Orange, California.

Sponsor
Nuvalent Inc.
Study ID
NCT05118789
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zidesamtinib (NVL-520) — DRUG
    Oral tablet of zidesamtinib (NVL-520)

Study Details

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.

Key Dates

Start date
Jan 4, 2022
Status verified
Jul 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
359 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 dose escalation
    Zidesamtinib (NVL-520) oral daily dosing
  • Experimental: Cohort 2a
    ROS1+ NSCLC naïve to TKI therapy and up to 1 prior chemotherapy and/or immunotherapy
  • Experimental: Cohort 2b
    ROS1+ NSCLC treated with 1 prior ROS1 TKI and no prior chemotherapy or immunotherapy
  • Experimental: Cohort 2c
    ROS1+ NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy
  • Experimental: Cohort 2d
    ROS1+ NSCLC treated with ≥2 prior ROS1 TKIs and up to 1 prior chemotherapy and/or immunotherapy
  • Experimental: Cohort 2e
    ROS1+ solid tumor and progressed on any prior therapy

Primary Outcome Measure

Maximum Tolerated Dose (MTD) (Phase 1) [ Time Frame: Within 28 days of last patient dosed during dose escalation ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
UCI Medical CenterOrangeCalifornia92868
Misako Nagasaka, MD, PhD (PRINCIPAL_INVESTIGATOR)
Stanford MedicinePalo AltoCalifornia94305
Joel Neal, MD, PhD (PRINCIPAL_INVESTIGATOR)
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Jonathan Riess, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado Cancer CenterDenverColorado80045
Ross Camidge, MD (PRINCIPAL_INVESTIGATOR)
Georgetown University Medical CenterWashington D.C.District of Columbia20007
Stephen Liu, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiCoral GablesFlorida33146
Gilberto de Lima Lopes, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Marina Garassino, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Alice Shaw, MD, PhD (PRINCIPAL_INVESTIGATOR)
Mass General HospitalBostonMassachusetts02114
Jessica Lin, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Cancer InstituteDetroitMichigan48202
Shirish Gadgeel, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Saiama Waqar, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Alexander Drilon, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Elaine Shum, MD (PRINCIPAL_INVESTIGATOR)
Atrium Health Levine Cancer InstituteCharlotteNorth Carolina28204
Daniel Haggstrom, MD (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43210
Dwight Owen, MD, MS (PRINCIPAL_INVESTIGATOR)
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Jessica Bauman, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research InstituteNashvilleTennessee37203
Melissa Johnson, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030-
NEXT Oncology - Virginia Cancer SpecialistsFairfaxVirginia22031
Alexander Spira, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Washington / Fred Hutchinson Cancer CenterSeattleWashington98109
Christina Baik, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Orange, CA

By research site
UCI Medical Center· Orange, CAStanford Medicine· Palo Alto, CAUC Davis Comprehensive Cancer Center· Sacramento, CAUniversity of Colorado Cancer Center· Denver, COGeorgetown University Medical Center· Washington D.C., DCUniversity of Miami· Coral Gables, FL

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