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A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
Trial Status: active
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.
Inclusion Criteria
Age ≥18 years (Cohort 2e only: Age ≥12 years and weighing>40 kg).
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.
Exclusion Criteria
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 study drug.
Ongoing anticancer therapy.
Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.
Additional locations may be listed on ClinicalTrials.gov for NCT05118789.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
