Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer

NCT ID: NCT05403385

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-26
• Study Completion Date: 2025-10-31

Brief Summary

The study will first determine the optimal dose of inupadenant to be given in combination with carboplatin and pemetrexed to patients that progressed after receiving first line anti-PD(L)1 treatment for locally advanced or metastatic non-small cell lung cancer. The efficacy and safety of the combination is then compared to standard of care carboplatin and pemetrexed in the same populations.

Detailed Description

The study is composed of two parts. Part 1 follows an open-label, dose-finding design where individual cohorts are treated with various dose levels of inupadenant combined with standard of care dosing of carboplatin and pemetrexed. The recommended phase 2 dose is determined prior to initiation of Part 2 which then compares inupadenant to placebo with both arms treated in combination with standard of care carboplatin and pemetrexed.

Participants in both parts are enrolled from two populations of patients with nonsquamous NSCLC that have progressed after first line treatment as follows: non-resectable patients treated with chemoradiotherapy followed by anti-PD-(L)1 or metastatic patients treated with anti-PD-(L)1 therapy without chemotherapy.

Imaging, safety and PRO assessments are performed during the treatment and follow-up phase as well as pharmacokinetic and other exploratory analyses.

Conditions

Metastatic NSCLC - Non-Small Cell Lung Cancer; Locally Advanced NSCLC - Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part 1, open label

Inupadenant will be given at one or more dose levels to determine the recommended Phase 2 dose (RP2D).

Group Type: EXPERIMENTAL

inupadenant

Intervention Type: DRUG

Adenosine 2a receptor antagonist

Carboplatin

Intervention Type: DRUG

standard of care chemotherapeutic, alkylating agent

Pemetrexed

Intervention Type: DRUG

standard of care chemotherapeutic, anti-metabolite

Part 2, active treatment

Treatment with inupadenant combined with carboplatin and pemetrexed

Group Type: EXPERIMENTAL

inupadenant

Intervention Type: DRUG

Adenosine 2a receptor antagonist

Carboplatin

Intervention Type: DRUG

standard of care chemotherapeutic, alkylating agent

Pemetrexed

Intervention Type: DRUG

standard of care chemotherapeutic, anti-metabolite

Part 2, placebo

Treatment with matched placebo combined with carboplatin and pemetrexed

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matched placebo capsule to inupadenant

Carboplatin

Intervention Type: DRUG

standard of care chemotherapeutic, alkylating agent

Pemetrexed

Intervention Type: DRUG

standard of care chemotherapeutic, anti-metabolite

Interventions

inupadenant

Adenosine 2a receptor antagonist

Intervention Type: DRUG

Placebo

matched placebo capsule to inupadenant

Intervention Type: DRUG

Carboplatin

standard of care chemotherapeutic, alkylating agent

Intervention Type: DRUG

Pemetrexed

standard of care chemotherapeutic, anti-metabolite

Intervention Type: DRUG

Other Intervention Names

EOS100850; Alimta

Eligibility Criteria

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.
• Existing biopsy taken within 4 years prior to entering trial or provide fresh biopsy where safe and feasible
• At least 12 weeks of treatment with only 1 anti-PD-(L)1 agent (mono or with IO combo) in the metastatic setting, OR at least 12 weeks of anti-PD-(L)1 agent (mono or with IO combo) following CRT in the unresectable, Stage III setting
• ECOG performance status of 0 to 1.

Exclusion Criteria

• Symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
• EGFR, ALK, or ROS1 mutation.
• Autoimmune disease requiring systemic treatment or immunodeficiency requiring concurrent use of systemic immunosuppressants or corticosteroids
• Hepatitis B or C infection unless adequately treated with no detectable viral load; Human immunodeficiency virus (HIV) unless well-controlled disease on therapy.
• History of life-threatening toxicity related to prior immune therapy
• Uncontrolled or significant cardiovascular disease
• Pregnant or breast-feeding
• Lack of agreement to use highly effective method of contraception during treatment and for 6 months after the last administration of chemotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

iTeos Belgium SA

INDUSTRY

Sponsor Role: collaborator

iTeos Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iteos Clinical Trials

Role: STUDY_DIRECTOR

iTeos Belgium SA

Locations

Highlands Oncology Group

Fayetteville, Arkansas, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Algemeen Ziekenhuis Sint-Lucas

Ghent, , Belgium

Jessa Ziekenhuis

Hasselt, , Belgium

AZ Delta

Roeselare, , Belgium

William Osler Health System

Brampton, Ontario, Canada

Vseobecna Fakultni Nemocnice

Prague, , Czechia

CHU de Caen

Caen, , France

Hopital de la Timone Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM)

Marseille, , France

CHU Nantes

Nantes, , France

Istituto Nazionale dei Tumori

Milan, , Italy

Gruppo Humanitas - Istituto Clinico Humanitas

Rozzano, , Italy

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, Spain

Complejo Hospitalario de Navarra (CHN)

Pamplona, Pamplona, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Valencia, Spain

Centro Oncologico de Galicia

A Coruña, , Spain

Hospital Infanta Cristina (Hospital Universitario de Badajoz)

Badajoz, , Spain

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Althaia Hospital

Manresa, , Spain

Complejo Hospitalario Universitario de Ourense

Ourense, , Spain

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Countries

United States; Belgium; Canada; Czechia; France; Italy; Spain; Switzerland

Other Identifiers

2024-515393-27-00

Identifier Type: CTIS

Identifier Source: secondary_id

A2A-005

Identifier Type: -

Identifier Source: org_study_id