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NCT06521554 · ClinicalTrials.gov record · last posted 2026-02-25

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

StatusRecruiting
PhasePhase 1
Started2024-07-18
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Phase 1a/1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330, determine the recommended Phase 2 dose (RP2D), and evaluate the antitumor activity in participants with advanced or metastatic human epidermal growth factor receptor 2 (HER2) -altered non-small lung cancer (NSCLC). Phase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2D(s) and, if applicable, the MTD. Phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2D(s) of NVL-330 and to determine the RP2D of NVL-330 in participants with advanced or metastatic HER2 mutant NSCLC.

Amendment record 12 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 12 times since 2024-07-25; most recent amendment 2026-02-23. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

Trial Details
NCT Number NCT06521554
Lead Sponsor Nuvalent Inc.
Conditions Locally Advanced Solid Tumor, Metastatic Solid Tumor
Enrollment 200 participants
Start Date 2024-07-18
Primary Completion 2027-01 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-02-25