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

RECRUITINGPhase 1/2Sponsored by Nuvalent Inc.
Actively Recruiting
PhasePhase 1/2
SponsorNuvalent Inc.
Started2022-01-04
Est. completion2027-12-31
Eligibility
Age12 Years+
Healthy vol.Accepted
Locations20 sites
View on ClinicalTrials.gov →

NCT05118789

Summary

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.

Eligibility

Age: 12 Years+Healthy volunteers accepted
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.

Conditions3

CancerLocally Advanced Solid TumorMetastatic Solid Tumor

Locations20 sites

UCI Medical Center
Orange, California, 92868
Misako Nagasaka, MD, PhD
Stanford Medicine
Palo Alto, California, 94305
Joel Neal, MD, PhD
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Jonathan Riess, MD
University of Colorado Cancer Center
Denver, Colorado, 80045
Ross Camidge, MD
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Stephen Liu, MD

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