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

Last updated: September 4, 2024
Sponsor: iTeos Therapeutics
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

inupadenant

Pemetrexed

Clinical Study ID

NCT05403385
A2A-005
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofexpression are eligible.

  • Existing biopsy taken within 4 years prior to entering trial or provide fresh biopsywhere safe and feasible

  • At least 12 weeks of treatment with only 1 anti-PD-(L)1 agent (mono or with IOcombo) in the metastatic setting, OR at least 12 weeks of anti-PD-(L)1 agent (monoor with IO combo) following CRT in the unresectable, Stage III setting

  • ECOG performance status of 0 to 1.

Exclusion

Exclusion Criteria:

  • Symptomatic central nervous system (CNS) metastases or leptomeningeal disease.

  • EGFR, ALK, or ROS1 mutation.

  • Autoimmune disease requiring systemic treatment or immunodeficiency requiringconcurrent 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 treatmentand for 6 months after the last administration of chemotherapy

Study Design

Total Participants: 186
Treatment Group(s): 4
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 26, 2022
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • Algemeen Ziekenhuis Sint-Maarten

    Mechelen, Antwerp 2800
    Belgium

    Active - Recruiting

  • Algemeen Ziekenhuis Sint-Lucas

    Gent, 9000
    Belgium

    Active - Recruiting

  • Jessa Ziekenhuis

    Hasselt, 3500
    Belgium

    Active - Recruiting

  • C.H.U. Ambroise Pare

    Mons, 7000
    Belgium

    Active - Recruiting

  • C.H.U. Ambroise Paré

    Mons, 7000
    Belgium

    Active - Recruiting

  • CHU UCL Namur

    Namur, 5000
    Belgium

    Active - Recruiting

  • CHU UCL Namur - site Sainte-Elisabeth

    Namur, 5000
    Belgium

    Active - Recruiting

  • AZ Delta

    Roeselare, 8800
    Belgium

    Active - Recruiting

  • University of Alberta - Cross Cancer Institute (CCI)

    Edmonton, Alberta AB T6G 1Z2
    Canada

    Active - Recruiting

  • William Osler Health System

    Brampton, Ontario L6R 3J7
    Canada

    Active - Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 77500
    Czechia

    Active - Recruiting

  • Vseobecna Fakultni Nemocnice

    Praha, 1300
    Czechia

    Site Not Available

  • Vseobecna Fakultni Nemocnice

    Praha 3, 116401
    Czechia

    Active - Recruiting

  • Hopital Saint Andre - CHU de Bordeaux

    Bordeaux, 33075
    France

    Active - Recruiting

  • Hopital Saint André - CHU de Bordeaux

    Bordeaux, 33075
    France

    Active - Recruiting

  • Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, 33076
    France

    Active - Recruiting

  • CHU de Caen

    Caen, 14003
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal de Creteil

    Créteil,
    France

    Active - Recruiting

  • Centre Georges Francois Leclerc

    Dijon, 21079
    France

    Active - Recruiting

  • Centre Georges François Leclerc

    Dijon, 21079
    France

    Active - Recruiting

  • Centre Leon Berard

    Lyon, 69008
    France

    Active - Recruiting

  • Hopital Nord de Marseille

    Marseille, 13385
    France

    Active - Recruiting

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

    Marseille, 13005
    France

    Active - Recruiting

  • CHU Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • HIA Begin

    Saint-Mandé, 94160
    France

    Active - Recruiting

  • Hôpital d'Instruction des Armées Bégin (HIA Bégin)

    Saint-Mandé, 94160
    France

    Active - Recruiting

  • Universitätsklinikum Gießen Und Marburg Gmbh (UKGM)

    Giessen, Hessen 35392
    Germany

    Active - Recruiting

  • Klinikum Chemnitz

    Chemnitz, 09116
    Germany

    Active - Recruiting

  • Evang. Kliniken Essen Mitte GmbH

    Essen, 45136
    Germany

    Active - Recruiting

  • Thoraxklinik-Heidelberg Ggmbh

    Heidelberg, 69126
    Germany

    Active - Recruiting

  • Kliniken der Stadt Köln gGmbH

    Köln, 51067
    Germany

    Active - Recruiting

  • Klinik Loewenstein gGmbH, Klinik für Thorakale Onkologie und Palliativmedizin

    Lowenstein, 74245
    Germany

    Active - Recruiting

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, 83100
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • Ospedale San Luca

    Lucca, 55100
    Italy

    Active - Recruiting

  • Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico

    Milan, 20133
    Italy

    Active - Recruiting

  • Istituto Nazionale dei Tumori

    Milano, 20133
    Italy

    Active - Recruiting

  • AOU San Luigi Gonzaga - SCDU

    Orbassano, 10043
    Italy

    Active - Recruiting

  • Oncologia Casa Di Cura Polispecialistica Dott Pederzoli

    Peschiera del Garda, 37019
    Italy

    Active - Recruiting

  • Gruppo Humanitas - Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

    Warszawa, Mazowieckie 02-781
    Poland

    Terminated

  • Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie

    Olsztyn, Warminsko-Mazurskie 10-357
    Poland

    Terminated

  • NZOZ Medpolonia Sp. Z o.o.

    Poznan, Wielkopolskie 60-693
    Poland

    Terminated

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o

    Krakow, 31-826
    Poland

    Terminated

  • Nzoz Formed 2

    Oświęcim, 32-600
    Poland

    Terminated

  • NZOZ Ars Medical Sp. z o.o.

    Piła, 64-920
    Poland

    Terminated

  • Uniwersytet Medyczny w Lodzi Klinika Pulmonologii Ogolnej i Onkologicznej

    Łódź, 90-549
    Poland

    Terminated

  • Hospital Universitari Son Espases

    Palma De Mallorca, Illes Balears 07120
    Spain

    Active - Recruiting

  • Hospital Universitario Son Espases

    Palma De Mallorca, Illes Balears 07120
    Spain

    Active - Recruiting

  • Centro Oncologico de Galicia

    A Coruña, 15009
    Spain

    Site Not Available

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hospital Infanta Cristina

    Badajoz, 06080
    Spain

    Active - Recruiting

  • Hospital Infanta Cristina (Hospital Universitario de Badajoz)

    Badajoz, 06080
    Spain

    Active - Recruiting

  • Hospital Quiron Barcelona - Instituto Oncologico Baselga

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Consorcio Hospitalario Provincial de Castellon

    Castellón De La Plana, 12002
    Spain

    Active - Recruiting

  • Centro Oncologico de Galicia

    Coruña, 15009
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, 27003
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Althaia Hospital

    Manresa, 08243
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Ourense

    Ourense, 10090
    Spain

    Active - Recruiting

  • Complejo Hospitalario de Navarra (CHN)

    Pamplona, 37008
    Spain

    Active - Recruiting

  • Hospital Universitario Marques De Valdecilla

    Santander,
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Active - Recruiting

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011
    Switzerland

    Active - Recruiting

  • HFR Fribourg

    Villars-sur-Glâne, 1752
    Switzerland

    Active - Recruiting

  • HFR Fribourg - Cantonal Hospital

    Villars-sur-Glâne, 1752
    Switzerland

    Active - Recruiting

  • Stadt Zuerich Stadtspital Triemli

    Zürich, 8063
    Switzerland

    Active - Recruiting

  • Stadtspital Zürich Triemli

    Zürich, 8063
    Switzerland

    Active - Recruiting

  • Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT
    United Kingdom

    Active - Recruiting

  • Highlands Oncology Group

    Fayetteville, Arkansas 72703
    United States

    Active - Recruiting

  • Innovative Clinical Research Institute (ICRI)

    Whittier, California 90603
    United States

    Terminated

  • Mid-Florida Hematology & Oncology Centers, PA

    Orange City, Florida 32763
    United States

    Terminated

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska 68310
    United States

    Active - Recruiting

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska 68310
    United States

    Terminated

  • Summit Medical Group PA

    Florham Park, New Jersey 07932
    United States

    Terminated

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina 28303
    United States

    Active - Recruiting

  • Carolina Institute for Clinical Research (Cumberland County Hospital System)

    Fayetteville, North Carolina 28303
    United States

    Terminated

  • Gabrail Cancer & Research Center

    Canton, Ohio 44718
    United States

    Terminated

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania 17325
    United States

    Terminated

  • UT Health East Texas HOPE Cancer Center

    Tyler, Texas 75701
    United States

    Active - Recruiting

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