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Brief Title: Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating Efficacy and Safety of Inupadenant in Combination With Carboplatin and Pemetrexed in Adults With Nonsquamous Non-small Cell Lung Cancer Who Have Progressed on Immunotherapy
Study ID: NCT05403385
Brief Summary: Part 1 of the study determines the optimal dose of inupadenant to be given in combination with carboplatin and pemetrexed to patients that progressed after receiving specific first line treatments for Stage 3 or metastatic non-small cell lung cancer. Part 2 compares the efficacy of inupadenant to placebo when both are combined with carboplatin and pemetrexed for patients that progressed after receiving the same first line treatments for Stage 3 or metastatic non-small cell lung cancer.
Detailed Description: In both Part 1 and Part 2, there are two nonsquamous NSCLC patient populations eligible for the study treatment: 1)patients with Stage III, non-resectable cancer that have received chemoradiotherapy, followed by durvalumab, and then have progressed; 2)patients who have received only first-line immunotherapy with anti-PD-L1 therapy, but no chemotherapy, in the metastatic setting, then progressed. In Part 1, all participants receive open-label inupadenant with standard of care doses of carboplatin and pemetrexed. Carboplatin is given at q3week intervals for no more than 4 cycles; pemetrexed continues at q3week as prescribed by the Investigator. Inupadenant is given orally BID. Dose-limiting toxicities are monitored during the first 21 days of treatment and a modified 3+3 escalation method is utilized to determine the recommended phase 2 dose (RP2D). Imaging and safety and PRO assessments are performed during the treatment and follow-up phase. Treatment continues until progression, withdrawal of consent, start of new anti-cancer treatment, end of study, or death. Part 2 is double-blinded, with subjects randomized 1:1 to receive the RP2D of inupadenant or matched placebo. All subjects receive the carboplatin and pemetrexed per standard of care. Imaging, safety and PRO assessments are performed during the treatment and follow-up phase. Treatment continues until progression, withdrawal of consent, start of new anti-cancer treatment, end of study, or death. In both Parts 1 and 2, blood samples are drawn to further define the pharmacokinetic profile of inupadenant and biosamples are collected for additional exploratory analyses.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Highlands Oncology Group, Fayetteville, Arkansas, United States
Innovative Clinical Research Institute (ICRI), Whittier, California, United States
Mid-Florida Hematology & Oncology Centers, PA, Orange City, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Summit Medical Group PA, Florham Park, New Jersey, United States
Carolina Institute for Clinical Research, Fayetteville, North Carolina, United States
Gabrail Cancer & Research Center, Canton, Ohio, United States
Gettysburg Cancer Center, Gettysburg, Pennsylvania, United States
UT Health East Texas HOPE Cancer Center, Tyler, Texas, United States
Algemeen Ziekenhuis Sint-Lucas, Gent, , Belgium
Jessa Ziekenhuis, Hasselt, , Belgium
Algemeen Ziekenhuis Sint-Maarten, Mechelen, , Belgium
C.H.U. Ambroise Pare, Mons, , Belgium
CHU UCL Namur, Namur, , Belgium
AZ Delta, Roeselare, , Belgium
William Osler Health System, Brampton, Ontario, Canada
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Vseobecna Fakultni Nemocnice, Praha, , Czechia
Vseobecna Fakultni Nemocnice, Praha, , Czechia
Hopital Saint Andre - CHU de Bordeaux, Bordeaux, , France
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux, , France
CHU de Caen, Caen, , France
Centre Georges Francois Leclerc, Dijon, , France
Hopital Nord de Marseille, Marseille, , France
HIA Begin, Saint-Mandé, , France
Azienda Ospedaliera Spedali Civili di Brescia, Brescia, , Italy
Ospedale San Luca, Lucca, , Italy
Istituto Nazionale dei Tumori, Milano, , Italy
Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico, Milan, , Italy
Oncologia Casa Di Cura Polispecialistica Dott Pederzoli, Peschiera del Garda, , Italy
Gruppo Humanitas - Istituto Clinico Humanitas, Rozzano, , Italy
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie, Warszawa, Mazowieckie, Poland
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie, Olsztyn, Warminsko-Mazurskie, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o, Krakow, , Poland
Nzoz Formed 2, Oświęcim, , Poland
NZOZ Ars Medical Sp. z o.o., Piła, , Poland
NZOZ Medpolonia Sp. Z o.o., Poznan, , Poland
Uniwersytet Medyczny w Lodzi Klinika Pulmonologii Ogolnej i Onkologicznej, Łódź, , Poland
Hospital Universitario Son Espases, Palma De Mallorca, Illes Balears, Spain
Centro Oncologico de Galicia, A Coruña, , Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital Infanta Cristina, Badajoz, , Spain
Hospital Quiron Barcelona - Instituto Oncologico Baselga, Barcelona, , Spain
Consorcio Hospitalario Provincial de Castellon, Castellón De La Plana, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Althaia Hospital, Manresa, , Spain
Complejo Hospitalario Universitario de Ourense, Ourense, , Spain
Complejo Hospitalario de Navarra (CHN), Pamplona, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
HFR Fribourg, Villars-sur-Glâne, , Switzerland
Stadt Zuerich Stadtspital Triemli, Zürich, , Switzerland