- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05742607
IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)
Official Title: A Phase II Multicenter, Open Label, Non-randomized Study of Neoadjuvant and Adjuvant Treatment With IPH5201 and Durvalumab in Patients With Resectable, Early-stage (II to IIIA) Non-Small Cell Lung Cancer (MATISSE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Innate Pharma
- Phone Number: +33484903084
- Email: clinical.trials@innate-pharma.fr
Study Locations
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Angers, France, 49333
- Recruiting
- Angers University Hospital Center
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Contact:
- Jose Hureaux
-
Caen, France, 14033
- Recruiting
- University Hospital Center Caen
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Contact:
- Simon DESHAYES
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Lille, France, 59037
- Not yet recruiting
- Hospital Calmette
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Contact:
- Alexis Cortot
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Limoges, France, 87042
- Recruiting
- Chu de Limoges
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Contact:
- Thomas Egenod
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Lyon, France, 69373
- Recruiting
- Léon Bérard Center
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Contact:
- Maurice Perol
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Marseille, France, 13015
- Recruiting
- Marseille University Hospital Center - North Hospital
-
Contact:
- Laurent GREILLIER
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Rennes, France, 35033
- Recruiting
- Rennes University Hospital Center - Hospital Pontchaillou
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Contact:
- Herve Lena
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Rouen, France, 76031
- Recruiting
- Charles Nicolle Hospital
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Contact:
- Florian GUISIER
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Villejuif, France, 94805
- Recruiting
- Gustave Roussy
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Contact:
- Fabrice Barlesi
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Athens, Greece, 11526
- Recruiting
- Henry Dunant Hospital Center
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Contact:
- Loannis Mountzios
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Athens, Greece, 12462
- Recruiting
- University General Hospital "Attikon"
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Contact:
- Amanda Psyrri
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Ioánnina, Greece, 45500
- Recruiting
- University General Hospital of Ioannina
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Contact:
- Mauri Davide
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Patras, Greece, 26504
- Recruiting
- University General Hospital of Patras
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Contact:
- Angelos Koutras
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Budapest, Hungary, H-1121
- Recruiting
- Koranyi National Institute of Pulmonology, 14th Department of Pulmonology
-
Contact:
- Gabriella Temesi
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Farkasgyepu, Hungary, 8582
- Recruiting
- Veszprem County Pulmonology Institute
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Contact:
- Zsolt Kiraly
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Győr, Hungary, 9024
- Recruiting
- Petz Aladar University Teaching Hospital, Department of Pulmonology
-
Contact:
- Zsuzsanna Szalai
-
Szolnok, Hungary, H-5000
- Recruiting
- Jasz-Nagykun-Szolnok County Hetenyi Geza Hospital-Clinic, Department of Oncology
-
Contact:
- Tobor Csoszi
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Torokbalint, Hungary, H-2045
- Not yet recruiting
- Pulmonology Institute Torokbalint
-
Contact:
- Gabriella Galffy
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-
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Bialystok, Poland, 15-540
- Recruiting
- University Teaching Hospital in Bialystok, 2nd Department of Lung Diseases and Tuberculosis
-
Contact:
- Robert Mroz
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Krąków, Poland, 31-202
- Recruiting
- John Paul II Specialist Hospital in Krakow
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Contact:
- Jaroslaw Kuzdzal
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Lublin, Poland, 20-093
- Recruiting
- Mandziuk Slawomir - Specialist Medical Practice
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Contact:
- Slawomir Mandziuk
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Poznań, Poland, 60-569
- Recruiting
- Eugenia and Janusz Zeyland Wielkopolskie Centre of Pulmonology and Thoracic Surgery
-
Contact:
- Katarzyna Stencel
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Prabuty, Poland, 82-550
- Recruiting
- Specialist Hospital in Prabuty Sp. z o.o. (LLC)
-
Contact:
- Anna Lowczak
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Warsaw, Poland, 04-141
- Recruiting
- Military Institute of Medicine - National Research Institute
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Contact:
- Renata Duchnowska
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Florida
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Saint Petersburg, Florida, United States, 33705
- Recruiting
- St. Anthony's Hospital - BayCare Health System
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Contact:
- Ahmad Shaker
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Tampa, Florida, United States, 33612
- Recruiting
- H. Lee Moffitt Cancer Center & Research Institute
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Contact:
- Alberto Chiappori
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Illinois
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Chicago, Illinois, United States, 60637
- Not yet recruiting
- University of Chicago Medical Center
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Contact:
- Everett Vokes
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New York
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Lake Success, New York, United States, 11042
- Not yet recruiting
- Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics
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Contact:
- Nagashree Seetharamu
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Texas
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Houston, Texas, United States, 77090
- Recruiting
- Millennium Research & Clinical Development
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Contact:
- Anirudha Dasgupta
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Wisconsin
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Madison, Wisconsin, United States, 53792
- Recruiting
- UW Carbone Cancer Center - Cancer Connect
-
Contact:
- Vincent Ma
- Phone Number: 800-622-8922
- Email: cancerconnect@uwcarbone.wisc.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC resectable (Stage IIA to Stage IIIA) disease (according to Version 8 of IASLC Staging Manual in Thoracic Oncology 2016.
- WHO Performance Status or Eastern Cooperative Oncology Group of 0 or 1.
- Adequate organ and marrow function.
- Must have a life expectancy of at least 12 weeks.
- Body weight > 35 kg.
- Females of childbearing potential should use an acceptable method of contraception from the time of screening throughout the total duration of the study.
- Negative pregnancy test (serum or urine) for women of childbearing potential.
- 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.
- Provision of tumor samples appropriate for exploratory biomarker analyses.
- 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.
- A pre- or post-bronchodilator FEV1 of 1.0 L and DLCO > 40% postoperative predicted value.
Exclusion Criteria:
- Participants with sensitising EGFR mutations or ALK translocations.
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders.
- 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.
- 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.
- History of another primary malignancy.
- Patients with small-cell lung cancer or mixed small-cell lung cancer.
- History of active primary immunodeficiency.
- 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.
- Patients who have preoperative radiotherapy treatment as part of their care plan.
- Patients who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon, to obtain potentially curative resection of primary tumor.
- 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).
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
- Patients with moderate or severe cardiovascular disease.
- 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.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.
- Major surgical procedure (as defined by the Investigator) within 30 days prior to the first dose of study drugs.
- Prior exposure to immune-mediated therapy.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs.
- Participation in another clinical study with an investigational product administered within 30 days prior to enrolment.
- Previous study drugs (durvalumab, IPH5201) assignment in the present study.
- 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.
- Involvement in the planning and/or conduct of the study (applies to both company staff and/or staff at the study site).
- 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.
- Exclusion criteria for participation in the optional (DNA) genetics research component.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathological Complete Response (pCR)
Time Frame: 16 weeks after the first dose of study intervention.
|
Number of patients with pathological Complete Response (pCR)
|
16 weeks after the first dose of study intervention.
|
Adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Until Day 90 after the last dose of study interventions.
|
Number of patients with adverse events (AEs) and serious adverse events (SAEs).
|
Until Day 90 after the last dose of study interventions.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event-Free Survival (EFS)
Time Frame: Up to approximately 2 years.
|
Number of patients experiencing an Event-Free Survival (EFS) event.
|
Up to approximately 2 years.
|
Disease Free Survival (DFS)
Time Frame: Up to approximately 2 years.
|
Number of patients experiencing a Disease Free Survival (DFS) event (event from surgery onwards).
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Up to approximately 2 years.
|
Surgical resection
Time Frame: Approximately 16 weeks after the first dose of study intervention.
|
Number of participants having surgical resection.
|
Approximately 16 weeks after the first dose of study intervention.
|
Major Pathological Response (mPR)
Time Frame: Approximately 16 weeks after the first dose of study intervention.
|
Number of patients with a major Pathological Response (mPR).
|
Approximately 16 weeks after the first dose of study intervention.
|
Objective Response Rate (ORR)
Time Frame: Up to approximately 4 months adjuvant.
|
Number of patients with an Objective Response Rate (ORR).
|
Up to approximately 4 months adjuvant.
|
Overall Survival (OS)
Time Frame: Up to approximately 2 years.
|
Overall Survival (OS).
|
Up to approximately 2 years.
|
PK of IPH5201 in combination with durvalumab +/- chemotherapy
Time Frame: Up to approximately 4 months adjuvant.
|
Serum concentration (PK) of IPH5201 in combination with durvalumab +/- chemotherapy, in patients receiving neoadjuvant and adjuvant treatment.
|
Up to approximately 4 months adjuvant.
|
Anti-study drug antibodies (ADA)
Time Frame: Up to approximately 4 months adjuvant.
|
Number of patients with anti-study drug antibodies (ADA).
|
Up to approximately 4 months adjuvant.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Folic Acid Antagonists
- Carboplatin
- Paclitaxel
- Cisplatin
- Durvalumab
- Antibodies, Monoclonal
- Pemetrexed
Other Study ID Numbers
- IPH5201-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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