A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (HARMONi-3)

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Investigational drug late phase More information Active drug More information Low burden on patient More information

Trial Details

Sponsor: Summit Therapeutics (industry)

Phase: 3

Start date: Oct. 26, 2023

Planned enrollment: 400

Last updated in HealthScout: Dec 2024

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chevron Show for: Ivonescimab (AK112/SMT112)

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Trial ID: NCT05899608
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More trial details at ClinicalTrials.gov More info

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Goal: The primary goal of the trial is to evaluate the efficacy and safety of ivonescimab combined with chemotherapy compared to pembrolizumab with chemotherapy as a first-line treatment for patients with metastatic squamous non-small cell lung cancer (NSCLC), focusing on overall survival.

Patients: The trial targets adults aged 18 and over diagnosed with metastatic squamous NSCLC, who have not received prior systemic treatment for their metastatic condition. Patients must have an ECOG performance status of 0 or 1 and a life expectancy of at least three months. Individuals with small cell lung carcinoma, non-squamous NSCLC, or known actionable genomic alterations are excluded.

Design: This is a multicenter, Phase 3 trial employing a randomized and controlled design to assess comparative outcomes across multiple regions. A total of 400 participants will be allocated to either the experimental or active comparator arm.

Treatments: The investigational treatment arm involves the administration of ivonescimab in combination with chemotherapy. Ivonescimab is a novel antibody targeting potentially multiple pathways implicated in tumor cell survival and proliferation. Previous studies have suggested its efficacy in enhancing the anti-tumor effects of chemotherapy by modulating the immune system and directly inhibiting cancer growth. In contrast, the standard treatment arm will use pembrolizumab, an established checkpoint inhibitor that has shown efficacy in prolonging survival in NSCLC by blocking the PD-1/PD-L1 pathway, thus reinvigorating immune response against cancer cells.

Outcomes: Primary endpoint: Overall Survival (OS). Secondary endpoints include Progression-Free Survival (PFS) per RECIST v1.1 criteria, and safety assessment through the incidence and severity of adverse events. The study also observes the time to any significant abnormal laboratory test results, spanning up to four years.

Burden on patient: The trial places a moderate to low burden on patients. Routine blood work and imaging follow standard protocols similar to current care regimens which typically involve periodic assessments. Travel-related commitments are expected to be manageable, with potential visits spread over extended intervals. Participation does not necessitate frequent additional procedures or high-frequency assessments beyond those integral to standard cancer care. Realistically, patients will undergo evaluations common in oncological practice, which may not significantly disrupt daily life or exceed expectations for similar Phase 3 trials.

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Ottawa, Ontario, K1H8L6, Canada

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London, Ontario, N6A5W9, Canada

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Regina, Saskatchewan, S4T7T1, Canada

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Brest, 29200, France

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Caen, 14033, France

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Créteil, 94010, France

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Le Mans, 72000, France

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Marseille, 13915, France

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Montpellier, 34295, France

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Paris, 75000, France

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Pierre-Bénite, 69495, France

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Quimper, 29107, France

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Rennes, 35033, France

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Saint-Herblain, 44805, France

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Strasbourg, 67033, France

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Tours, 37044, France

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Villejuif, 94800, France

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Frankfurt, 60488, Germany

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Luebeck, 23538, Germany

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Kempten, 87435, Germany

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Jena, 07747, Germany

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Heidelberg, 69126, Germany

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Giesen, 35392, Germany

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Gauting, 82131, Germany

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Esslingen, 73730, Germany

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Athens, 11527, Greece

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Patra, 26443, Greece

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Patra, 26504, Greece

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Thessaloníki, 54622, Greece

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Thessaloníki, 57010, Greece

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Athens, 57010, Greece

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Athens, 15562, Greece

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Athens, 11528, Greece

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Dublin, D08 NHY1, Ireland

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Dublin, D09V2N0, Ireland

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Peschiera Del Garda, 37019, Italy

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Monterrey, 64060, Mexico

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Guadalajara, 44670, Mexico

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Monterrey, 64460, Mexico

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Monterrey, 64710, Mexico

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Łódź, 90-302, Poland

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Poznań, 60-693, Poland

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Belgrade, 11080, Serbia

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Niš, 18000, Serbia

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Belgrade, 11000, Serbia

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Kragujevac, 34000, Serbia

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Barcelona, 08035, Spain

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Badajoz, 06080, Spain

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Badalona, 08916, Spain

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Barcelona, 08003, Spain

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Barcelona, 08025, Spain

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Barcelona, 08028, Spain

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Barcelona, 08107, Spain

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Girona, 17007, Spain

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Jaén, 23007, Spain

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Lugo, 27003, Spain

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Madrid, 28040, Spain

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Madrid, 28046, Spain

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Pamplona, 31008, Spain

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Sevilla, 41013, Spain

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Valencia, 46010, Spain

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Summit Therapeutics Research Center

Valencia, 46206, Spain

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Vigo, 36312, Spain

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London, EC1A 7BE, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Tucson, Arizona, 85711, United States

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Little Rock, Arkansas, 72205, United States

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Sacramento, California, 95817, United States

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Los Angeles, California, 90067, United States

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Los Angeles, California, 90033, United States

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Santa Rosa, California, 95403, United States

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Santa Monica, California, 90404, United States

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Lone Tree, Colorado, 80124, United States

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Saint Petersburg, Florida, 33705, United States

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Plantation, Florida, 33322, United States

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Petersburg, Florida, 33709, United States

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Pensacola, Florida, 32503, United States

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Pembroke Pines, Florida, 33028, United States

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Palm Bay, Florida, 32901, United States

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Ocala, Florida, 34474, United States

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Jacksonville, Florida, 32256, United States

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Fort Myers, Florida, 33901, United States

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West Palm Beach, Florida, 33401, United States

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Lexington, Kentucky, 40503, United States

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Burlington, Massachusetts, 01805, United States

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Detroit, Michigan, 48202, United States

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Ann Arbor, Michigan, 48109, United States

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Saint Paul, Minnesota, 55101, United States

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Billings, Montana, 59102, United States

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New York, New York, 10065, United States

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New York, New York, 10029, United States

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Chapel Hill, North Carolina, 27514, United States

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Charlotte, North Carolina, 28204, United States

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Cleveland, Ohio, 44106, United States

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Cincinnati, Ohio, 45242, United States

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Cleveland, Ohio, 44195, United States

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Eugene, Oregon, 97401, United States

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Greenville, South Carolina, 29605, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78745, United States

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Dallas, Texas, 75246, United States

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Tyler, Texas, 75702, United States

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MD Anderson Cancer Center

Houston, Texas, 77030, United States

[email protected] / 713-563-6096

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Reston, Virginia, 20190, United States

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Norfolk, Virginia, 23502, United States

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Spokane, Washington, 99202, United States

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Seattle, Washington, 98103, United States

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Madison, Wisconsin, 53792, United States

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