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Naporafenib

Phase 3

Advanced or Metastatic NRAS-mutant Melanoma | Small molecule | Oncology |Erasca, Inc.|Last Updated: Feb 27, 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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment78
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06346067A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)PHASE3 ACTIVE NOT_RECRUITING 78 — — Apr 29, 2024Dec 1, 2028Feb 27, 202659 United States, Australia +7
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Study Endpoints
Primary Endpoints
Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2
Assessed up to 6 months from time of first dose

Incidence and severity of treatment-emergent AEs and serious AEs

Stage 2: To compare PFS and OS for patients who are randomized to receive the combination of naporafenib + trametinib to that of patients who receive physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy)
Assessed up to 24 months from time of first dose

* Progression free survival (PFS) based on assessment of radiographic imaging per RECIST v1.1 * Survival status

Secondary Endpoints
Adverse Events
Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Assessed up to 24 months from time of first dose]
Time to Response (TTR)
Assessed up to 24 months from time of first dose]
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Stage 1 Dose selection Lead-in Arm 1EXPERIMENTALNaporafenib + Trametinib Naporafenib (ERAS-254) 100 mg administered orally twice daily (BID) Trametinib 1 mg once daily (QD)
Stage 1 Dose selection Lead-in Arm 2EXPERIMENTALNaporafenib + Trametinib Naporafenib (ERAS-254) 400 mg administered orally twice daily (BID) Trametinib 0.5 mg once daily (QD)
Stage 1 Dose selection Lead-in Arm 3 Trametinib monotherapyACTIVE_COMPARATORTrametinib 2 mg once daily (QD)
Stage 2 Arm AEXPERIMENTALNaporafenib + Trametinib Naporafenib (ERAS-254) BID oral administration with Trametinib QD at the dose selected in Stage 1
Stage 2 Arm B - Physician's ChoiceACTIVE_COMPARATOR* Dacarbazine 1000 mg/m2 intravenously (IV) on Day 1 of each 21-day cycle OR * Temozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle OR * Trametinib monotherapy, 2 mg PO QD
Interventions
NameTypeDescription
NaporafenibDRUGNaporafenib (ERAS-254) is an experimental Pan-Raf inhibitor
DacarbazineDRUGDacarbazine IV - Day 1
TemozolomideDRUGTemozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle
TrametinibDRUGTrametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites59

Key Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Age ≥ 18 years 3. Histologically or cytologically confirmed unresectable or metastatic cutaneous (includes acral) melanoma. 4. Documentation of an NRAS mutation (tumor tissue or blood) prior to first dose of study dr...

Countries:United StatesAustraliaCanadaCzechiaFranceItalyNetherlandsSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06346067primaryCompletionDate: changed
LOWMay 24, 2026NCT06346067studyFirstPostDate: changed