A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
Recruiting
Phase 1
Phase 2
Interventional Study
Locally Advanced Solid Tumor
Metastatic Solid Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 359 (estimated)
- Sponsor
- Nuvalent Inc. · Industry
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About This Trial
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 zide…
Trial Locations
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Eligibility Criteria
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 cytological…
Contacts