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EIK1001

Phase 2

NSCLC | Small molecule | Other |Eikon Therapeutics, Inc.|Last Updated: May 28, 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 Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06246110A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLCPHASE2 ACTIVE NOT_RECRUITING 70Feb 6, 2024Dec 1, 2027May 28, 202638 United States
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Study Endpoints
Primary Endpoints
Percentage of participants with safety event during treatment
Up to 2 years

Defined AEs that occur during treatment and are deemed to be related EIK1001 or combination with SOC or due to disease progression or toxicity.

Secondary Endpoints
Percentage of participants with objective response rate (ORR) and duration of response (DOR).
Up to 4 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A - Participants with non-squamous NSCLCEXPERIMENTALParticipants in this arm will receive EIK1001 + Standard of Care (SOC).
Cohort B - Participants with squamous NSCLCEXPERIMENTALParticipants in this arm will receive EIK1001 + Standard of Care (SOC).
Interventions
NameTypeDescription
EIK1001DRUGEIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
PembrolizumabDRUGPD-1 inhibitor
PaclitaxelDRUGChemotherapy
PemetrexedDRUGChemotherapy
CarboplatinDRUGChemotherapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: 1. be ≥ 18 years of age on the day of signing of informed consent. 2. confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care. 3. have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mut...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 29, 2026NCT06246110Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMMay 29, 2026NCT06246110Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMMay 29, 2026NCT06246110Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT06246110primaryCompletionDate: changed
LOWMay 24, 2026NCT06246110studyFirstPostDate: changed