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NVL-330

Phase 1

Locally Advanced Solid Tumor | Small molecule | Oncology |Nuvalent, Inc.|Last Updated: Feb 25, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06521554A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)PHASE1 RECRUITING 200 — — Jul 18, 2024Feb 1, 2027Feb 25, 202621 United States, Australia +1
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Study Endpoints
Primary Endpoints
Recommended Phase 2 Dose (RP2D)
As determined by incidence of DLTs during the first 28 days of treatment (ie, Cycle 1)

To determine up to 2 RP2D Candidates

Maximum Tolerated Dose (MTD)
As determined by incidence of DLTs during the first 28 days of treatment (ie, Cycle 1)

If applicable, to determine the MTD

Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
First dose of study drug through 30 days after the last dose of study drug

Number of participants with TEAEs as assessed by CTCAE, v5.0

Secondary Endpoints
Effect of Food on Maximum Plasma Concentration (Cmax) of NVL-330
Pre-dose and up to 24 hours post-dose
Effect of Food on Area Under the Curve from Time 0 to 24 (AUC0-24) of NVL-330
Pre-dose and up to 24 hours post-dose
Effect of Food on Area Under the Curve from Time 0 to Infinity (AUCinf) of NVL-330
Pre-dose and up to 24 hours post-dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1a dose escalationEXPERIMENTALNVL-330 oral daily dosing
Phase 1b dose expansionEXPERIMENTALNVL-330 oral daily dosing
Interventions
NameTypeDescription
NVL-330DRUGOral Tablet of NVL-330
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC 3. Documented HER2 status as follows: 1. Phase 1a: Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations or single nucleotide variants or HER2 amplificati...

Countries:United StatesAustraliaCanada
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06521554primaryCompletionDate: changed
LOWMay 24, 2026NCT06521554studyFirstPostDate: changed