IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)
NCT ID: NCT05742607
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2023-06-23
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy.
Following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab
Study Groups
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IPH5201 + durvalumab + standard chemotherapy
Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy.
Following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab.
IPH5201 + durvalumab + standard chemotherapy
Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy.
Following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab.
Interventions
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IPH5201 + durvalumab + standard chemotherapy
Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy.
Following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. WHO Performance Status or Eastern Cooperative Oncology Group of 0 or 1.
3. Adequate organ and marrow function.
4. Must have a life expectancy of at least 12 weeks.
5. Body weight \> 35 kg.
6. Females of childbearing potential should use an acceptable method of contraception from the time of screening throughout the total duration of the study.
7. Negative pregnancy test (serum or urine) for women of childbearing potential.
8. Provision of tumor samples (newly acquired \[preferred\] or archival tumor tissue \[≤ 6 months old\]) to confirm Programmed Death-Ligand 1 status, Epidermal Growth Factor Receptor, or Anaplastic Lymphoma Kinase status.
9. Provision of tumor samples appropriate for exploratory biomarker analyses.
10. Patients will be suitable for inclusion if the planned surgery to be performed will be lobectomy, sleeve resection, or bilobectomy, as determined by the attending surgeon based on the baseline findings.
11. A pre- or post-bronchodilator FEV1 of 1.0 L and DLCO \> 40% postoperative predicted value.
Exclusion Criteria
2. History of allogeneic organ transplantation.
3. Active or prior documented autoimmune or inflammatory disorders.
4. Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement.
5. History of any grade of venous or arterial thromboembolic events including cerebrovascular accident, transient ischemic attack, or unstable angina pectoris within 6 months prior to enrollment.
6. History of another primary malignancy.
7. Patients with small-cell lung cancer or mixed small-cell lung cancer.
8. History of active primary immunodeficiency.
9. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBsAg result) and HCV. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
10. Patients who have preoperative radiotherapy treatment as part of their care plan.
11. Patients who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon, to obtain potentially curative resection of primary tumor.
12. QTc interval ≥ 470 ms (NOTE: If prolonged, then 2 additional ECGs should be obtained and the average QTcF interval should be used to determine eligibility).
13. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
14. Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
15. Patients with moderate or severe cardiovascular disease.
16. Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
17. Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.
18. Major surgical procedure (as defined by the Investigator) within 30 days prior to the first dose of study drugs.
19. Prior exposure to immune-mediated therapy.
20. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs.
21. Participation in another clinical study with an investigational product administered within 30 days prior to enrolment.
22. Previous study drugs (durvalumab, IPH5201) assignment in the present study.
23. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of study drugs administration.
24. Involvement in the planning and/or conduct of the study (applies to both company staff and/or staff at the study site).
25. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
18 Years
ALL
No
Sponsors
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Innate Pharma
INDUSTRY
Responsible Party
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Locations
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St. Anthony's Hospital - BayCare Health System
St. Petersburg, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics
Lake Success, New York, United States
Millennium Research & Clinical Development
Houston, Texas, United States
UW Carbone Cancer Center - Cancer Connect
Madison, Wisconsin, United States
Angers University Hospital Center
Angers, , France
University Hospital Center Caen
Caen, , France
Hospital Calmette
Lille, , France
CHU de Limoges
Limoges, , France
Leon Berard Center
Lyon, , France
Marseille University Hospital Center - North Hospital
Marseille, , France
Rennes University Hospital Center - Hospital Pontchaillou
Rennes, , France
Charles Nicolle Hospital
Rouen, , France
Gustave Roussy
Villejuif, , France
Henry Dunant Hospital Center
Athens, , Greece
University General Hospital "Attikon"
Athens, , Greece
University General Hospital of Ioannina
Ioannina, , Greece
University General Hospital of Patras
Pátrai, , Greece
Koranyi National Institute of Pulmonology, 14th Department of Pulmonology
Budapest, , Hungary
Veszprem County Pulmonology Institute
Farkasgyepű, , Hungary
Petz Aladar University Teaching Hospital, Department of Pulmonology
Győr, , Hungary
Jasz-Nagykun-Szolnok County Hetenyi Geza Hospital-Clinic, Department of Oncology
Szolnok, , Hungary
Pulmonology Institute Torokbalint
Törökbálint, , Hungary
University Teaching Hospital in Bialystok, 2nd Department of Lung Diseases and Tuberculosis
Bialystok, , Poland
John Paul II Specialist Hospital in Krakow
Krąków, , Poland
Mandziuk Slawomir - Specialist Medical Practice
Lublin, , Poland
Eugenia and Janusz Zeyland Wielkopolskie Centre of Pulmonology and Thoracic Surgery
Poznan, , Poland
Specialist Hospital in Prabuty Sp. z o.o. (LLC)
Prabuty, , Poland
Military Institute of Medicine - National Research Institute
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Ahmad Shaker
Role: primary
Alberto Chiappori
Role: primary
Everett Vokes
Role: primary
Nagashree Seetharamu
Role: primary
Anirudha Dasgupta
Role: primary
Jose Hureaux
Role: primary
Simon Deshayes
Role: primary
Alexis Cortot
Role: primary
Thomas Egenod
Role: primary
Maurice Perol
Role: primary
Laurent Greillier
Role: primary
Herve Lena
Role: primary
Florian Guisier
Role: primary
Fabrice Barlesi
Role: primary
Loannis Mountzios
Role: primary
Amanda Psyrri
Role: primary
Mauri Davide
Role: primary
Angelos Koutras
Role: primary
Gabriella Temesi
Role: primary
Zsolt Kiraly
Role: primary
Zsuzsanna Szalai
Role: primary
Tobor Csoszi
Role: primary
Gabriella Galffy
Role: primary
Robert Mroz
Role: primary
Jaroslaw Kuzdzal
Role: primary
Slawomir Mandziuk
Role: primary
Katarzyna Stencel
Role: primary
Anna Lowczak
Role: primary
Renata Duchnowska
Role: primary
Other Identifiers
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IPH5201-201
Identifier Type: -
Identifier Source: org_study_id
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