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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

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

inupadenant · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT05403385Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung CancerMetastatic NSCLC - Non-Small Cell Lung Cancer
ACTIVE NOT_RECRUITING36 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer
Metastatic NSCLC - Non-Small Cell Lung CancerUnlock trial analytics

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

Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving inupadenant
During the DLT evaluation period that is cycle 1 (each cycle is 4 weeks)

Incidence of adverse events (AEs), serious adverse events (SAEs), DLTs, AEs leading to discontinuation, deaths, electrocardiogram (ECG) abnormalities, and clinically significant laboratory abnormalities

Incidence and severity of AEs in patients receiving inupadenant
Through study completion, an average of 4 months

To assess safety and tolerability as measured by incidence and severity of AEs

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
Inupadenant sequential dose escalation (Part 1A)EXPERIMENTALPart 1A will evaluate the safety as well as to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of inupadenant in participants with advanced solid tumors.
Inupadenant randomized crossover (Part 1B)EXPERIMENTALThe effect of food on the exposure to inupadenant will be investigated in participants with advanced solid tumors.
Inupadenant single treatment assignment (Part 1C)EXPERIMENTALPart 1C will investigate an additional formulation of inupadenant in participants with advanced solid tumors.

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 to 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 StatesBelgiumCanadaCzechiaFranceItalySpainSwitzerlandUnited Kingdom
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Frequently asked questions about inupadenant

What is Inupadenant used for?

Inupadenant is an investigational small molecule being studied for the treatment of solid tumors, including metastatic non-small cell lung cancer (NSCLC) and locally advanced NSCLC. It is being evaluated in adult patients with cancer.

What does Inupadenant target?

Inupadenant is a small molecule designed to target the adenosine A2A receptor, which plays a role in tumor immune evasion. By blocking this receptor, it aims to enhance the immune system's ability to fight cancer cells.

Who is developing Inupadenant?

Inupadenant is being developed by iTeos Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ITOS.

What phase is Inupadenant in?

Inupadenant is in Phase 1 and Phase 2 clinical trials. A Phase 1 study has been completed, and a Phase 2 study is currently active but not recruiting participants.

What clinical trials is Inupadenant in?

Inupadenant is being studied in two clinical trials: NCT05117177, a completed Phase 1 study in patients with solid tumors, and NCT05403385, an active Phase 2 study in patients with nonsquamous non-small cell lung cancer.

Is Inupadenant the same as EOS100850?

Yes, Inupadenant is also known as EOS100850. Both names refer to the same investigational drug being developed by iTeos Therapeutics.