NCT05118789 · ClinicalTrials.gov record · last posted 2025-10-24
A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
StatusRecruiting
PhasePhase 1/2
Started2022-01-04
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from the ClinicalTrials.gov record
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.
Amendment record
33 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 33 times since 2021-11-03; most recent amendment 2025-10-22. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
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| NCT Number |
NCT05118789 |
| Lead Sponsor |
Nuvalent Inc.
|
| Conditions |
Locally Advanced Solid Tumor, Metastatic Solid Tumor |
| Enrollment |
359 participants |
| Start Date |
2022-01-04 |
| Primary Completion |
2027-12-31 (estimated) |
| Study Completion |
2028-12-31 (estimated) |
| Updated on ClinicalTrials.gov |
2025-10-24 |