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

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NCT06521554 · readout ≤ 165 d

Sponsored by Nuvalent Inc. (industry) · NUVL — their whole pipeline →.

Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
200estimated
Sites
21
Countries
Australia, Canada, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2024-07-18actualWhen the study began enrolling
Primary completionJan 2027estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionFeb 2027estimatedThe whole study's end, after follow-up
First posted2024-07-26actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-02-25actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Locally Advanced Solid Tumor
  • Metastatic Solid Tumor

Intervention

  • Drug: NVL-330

Primary outcomes

what the primary-completion date above is the date OF
Recommended Phase 2 Dose (RP2D)
measured As determined by incidence of DLTs during the first 28 days of treatment (ie, Cycle 1)
Maximum Tolerated Dose (MTD)
measured As determined by incidence of DLTs during the first 28 days of treatment (ie, Cycle 1)
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
measured First dose of study drug through 30 days after the last dose of study drug

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