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Study details
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A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)

Nuvalent Inc.
NCT IDNCT06521554ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1

Target enrollment

150

Study length

about 1.7 years

Ages

18+

Locations

17 sites in CA, CO, DC +11

About this study

This trial is testing a treatment called NVL-330 for people with advanced or metastatic lung cancer that has changes to the HER2 gene. The goal is to see if it's safe and effective, determine the best dose, and evaluate its potential to fight the cancer.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take NVL-330
PhasePhase 1
Primary goalIncidence and severity of Treatment Emergent Adverse Events (TEAEs)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low7%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

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

Endpoints

Primary: Incidence and severity of Treatment Emergent Adverse Events (TEAEs), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D)

Secondary: Duration of Response (DOR), Effect of Food on Maximum Plasma Concentration (Cmax) of NVL-330, Effect of Food on Time of Maximum Concentration (Tmax) of NVL-330, Half-life (t1/2) of NVL-330, Intracranial Duration of Response (IC-DOR), Intracranial Objective Response Rate (IC-ORR), Maximum plasma concentration (Cmax) of NVL-330, Maximum plasma concentration (Cmax- dose normalized) of NVL-330

Body systems

Oncology