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Study details
Enrolling now

A Study of Zidesamtinib (NVL-520)

Nuvalent Inc.
NCT IDNCT05118789ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

359

Study length

about 7 years

Ages

12+

Locations

20 sites in CA, CO, DC +13

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Zidesamtinib (NVL-520)
PhasePhase 1/Phase 2
DrugZidesamtinib (NVL-520)
Primary goalMaximum Tolerated Dose (MTD) (Phase 1)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low6%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

kinase inhibitor

Endpoints

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

Body systems

Oncology