A Study of Zidesamtinib (NVL-520)
Phase 1/2
359
about 7 years
12+
20 sites in CA, CO, DC +13
What this study is about
This trial is testing a treatment called zidesamtinib (NVL-520) in people with advanced NSCLC and other solid tumors that have ROS1 rearrangements. The goal is to see if the treatment is safe, how well it works, and what dose is best for further trial.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Zidesamtinib (NVL-520)
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
kinase inhibitor
Primary: Maximum Tolerated Dose (MTD) (Phase 1), Objective Response Rate (ORR) (Phase 2), Recommended Phase 2 Dose (RP2D)
Secondary: Clinical benefit rate (CBR), Duration of response (DOR), Half-life (t1/2) of NVL-520, Intracranial objective response rate (IC-ORR), Maximum plasma concentration (Cmax) of NVL-520, Number of participants with treatment-emergent adverse events, as assessed by CTCAE, v5.0, Objective response rate (ORR), Oral clearance (CL/F) of NVL-520
Oncology