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inupadenant

Phase 2

Metastatic NSCLC - Non-Small Cell Lung Cancer | Small molecule | Oncology |iTeos Therapeutics, Inc.|Last Updated: Aug 3, 2025

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05403385Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung CancerPHASE2 ACTIVE NOT_RECRUITING 36Aug 26, 2022Oct 1, 2025Aug 3, 202521 United States, Belgium +6
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Study Endpoints
Primary Endpoints
Dose-finding to determine recommended Phase 2 dose
At the end of Cycle 1 (each cycle is 21 days)

Incidence of dose-limiting toxicities

Incidence of treatment-emergent adverse events [Safety and Tolerability]
Duration of intervention (up to 24 months) plus 30 days follow-up or up to database lock

Incidence of adverse events (AEs), serious adverse events, AEs leading to discontinuation, deaths, and clinically significant laboratory abnormalities.

Progression-free survival [Efficacy]
From randomization to first-documented radiological progression or date of death from any cause, whichever comes first, assessed up to 24 months.

Time from first dose to the date of first documented radiologic progression per RECIST v1.1 or time of death, whichever comes first

Secondary Endpoints
Overall Response Rate [Efficacy]
From randomization to first-documented radiological improvement, if applicable, assessed up to 24 months or up to database lock.
Duration of Response [Efficacy]
From first-documented CR or PR to first radiological progression or date of death, whichever comes first, assessed up to 24 months or up to database lock.
Percent Change in Tumor Size [Efficacy]
From randomization to the documented radiological assessment with the smallest tumor size sum, assessed up to 24 months or up to database lock.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1, open labelEXPERIMENTALInupadenant will be given at one or more dose levels to determine the recommended Phase 2 dose (RP2D).
Part 2, active treatmentEXPERIMENTALTreatment with inupadenant combined with carboplatin and pemetrexed
Part 2, placeboPLACEBO_COMPARATORTreatment with matched placebo combined with carboplatin and pemetrexed
Interventions
NameTypeDescription
inupadenantDRUGAdenosine 2a receptor antagonist
PlaceboDRUGmatched placebo capsule to inupadenant
CarboplatinDRUGstandard of care chemotherapeutic, alkylating agent
PemetrexedDRUGstandard of care chemotherapeutic, anti-metabolite
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Confirmed diagnosis of metastatic (Stage IV) or locally advanced, unresectable (Stage III) NSCLC of nonsquamous pathology * Measurable disease as defined by RECIST v1.1 * PD-L1 expression status available at or after the time of diagnosis. All levels of expression are eligible...

Countries:United StatesBelgiumCanadaCzechiaFranceItalySpainSwitzerland
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05403385primaryCompletionDate: changed
LOWMay 24, 2026NCT05403385studyFirstPostDate: changed