At a glance
ClinicalIndex Comparison Record- ✓Locally advanced or metastatic solid tumor with ROS1 rearrangement (Phase 1) or NSCLC with ROS1 rearrangement (Phase 2 Cohorts 2a-2d) or non-NSCLC solid tumor with ROS1 rearrangement (Phase 2 Cohort 2e)
- ✓Measurable or evaluable disease per RECIST 1.1
- ✓Adequate baseline organ function and bone marrow reserve
- ✕Known oncogenic driver alteration other than ROS1
- ✕Allergy or hypersensitivity to NVL-520 excipients
- ✕Major surgery within 4 weeks of first dose
- ✕Ongoing anticancer therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Zidesamtinib (NVL-520) for Locally Advanced Solid Tumor and Metastatic Solid Tumor. Currently recruiting, targeting 359 participants across 63 sites in 14 countries.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Oral tablet of zidesamtinib (NVL-520)