Actively Recruiting
IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)
Led by Innate Pharma · Updated on 2025-05-16
70
Participants Needed
30
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is intended to assess the safety and efficacy of neoadjuvant combination of IPH5201 and durvalumab in addition to standard chemotherapy and adjuvant combination of IPH5201 and durvalumab in untreated patients with resectable, early-stage (stage II to IIIA) non-small cell lung cancer (NSCLC).
CONDITIONS
Official Title
IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed and untreated patients with histologically or cytologically confirmed resectable NSCLC Stage IIA to IIIA
- WHO Performance Status or ECOG of 0 or 1
- Adequate organ and bone marrow function
- Life expectancy of at least 12 weeks
- Body weight greater than 35 kg
- Females of childbearing potential must use effective contraception throughout the study
- Negative pregnancy test for women of childbearing potential
- Provision of tumor samples to confirm PD-L1, EGFR, or ALK status
- Provision of tumor samples for exploratory biomarker analyses
- Planned surgery must be lobectomy, sleeve resection, or bilobectomy as determined by the surgeon
- Pre- or post-bronchodilator FEV1 of at least 1.0 L and DLCO greater than 40% predicted postoperatively
You will not qualify if you...
- Presence of sensitizing EGFR mutations or ALK translocations
- History of allogeneic organ transplantation
- Active or prior autoimmune or inflammatory disorders
- Uncontrolled illness including hypertension, unstable angina, arrhythmia, active interstitial lung disease, serious gastrointestinal conditions, or psychiatric illness limiting compliance
- History of thromboembolic events including stroke or unstable angina within 6 months
- History of another primary cancer
- Small-cell lung cancer or mixed small-cell lung cancer diagnosis
- History of active primary immunodeficiency
- Active infections including tuberculosis, hepatitis B, or hepatitis C (with exceptions)
- Preoperative radiotherapy as part of care plan
- Requirement for pneumonectomy, segmentectomy, or wedge resection surgery
- QTc interval 470 ms or higher
- Allergy or hypersensitivity to study drugs or excipients
- Medical contraindications to chemotherapy
- Moderate or severe cardiovascular disease
- Concurrent cancer treatments excluding certain hormonal therapies
- Receipt of live vaccines within 30 days before first study dose
- Major surgery within 30 days before first study dose
- Prior immune-mediated therapy exposure
- Use of immunosuppressive medication within 14 days before first dose
- Participation in other investigational studies within 30 days
- Previous assignment to study drugs in this trial
- Pregnancy, breastfeeding, or unwillingness to use birth control during and after study
- Involvement in study planning or conduct
- Investigator judgment deeming patient unlikely to comply
- Exclusion criteria for optional genetics research component
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
St. Anthony's Hospital - BayCare Health System
St. Petersburg, Florida, United States, 33705
Actively Recruiting
2
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Actively Recruiting
3
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Not Yet Recruiting
4
Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics
Lake Success, New York, United States, 11042
Not Yet Recruiting
5
Millennium Research & Clinical Development
Houston, Texas, United States, 77090
Actively Recruiting
6
UW Carbone Cancer Center - Cancer Connect
Madison, Wisconsin, United States, 53792
Actively Recruiting
7
Angers University Hospital Center
Angers, France, 49333
Actively Recruiting
8
University Hospital Center Caen
Caen, France, 14033
Actively Recruiting
9
Hospital Calmette
Lille, France, 59037
Not Yet Recruiting
10
CHU de Limoges
Limoges, France, 87042
Actively Recruiting
11
Leon Berard Center
Lyon, France, 69373
Actively Recruiting
12
Marseille University Hospital Center - North Hospital
Marseille, France, 13015
Actively Recruiting
13
Rennes University Hospital Center - Hospital Pontchaillou
Rennes, France, 35033
Actively Recruiting
14
Charles Nicolle Hospital
Rouen, France, 76031
Actively Recruiting
15
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
16
Henry Dunant Hospital Center
Athens, Greece, 11526
Actively Recruiting
17
University General Hospital "Attikon"
Athens, Greece, 12462
Actively Recruiting
18
University General Hospital of Ioannina
Ioannina, Greece, 45500
Actively Recruiting
19
University General Hospital of Patras
Pátrai, Greece, 26504
Actively Recruiting
20
Koranyi National Institute of Pulmonology, 14th Department of Pulmonology
Budapest, Hungary, H-1121
Actively Recruiting
21
Veszprem County Pulmonology Institute
Farkasgyepű, Hungary, 8582
Actively Recruiting
22
Petz Aladar University Teaching Hospital, Department of Pulmonology
Győr, Hungary, 9024
Actively Recruiting
23
Jasz-Nagykun-Szolnok County Hetenyi Geza Hospital-Clinic, Department of Oncology
Szolnok, Hungary, H-5000
Actively Recruiting
24
Pulmonology Institute Torokbalint
Törökbálint, Hungary, H-2045
Not Yet Recruiting
25
University Teaching Hospital in Bialystok, 2nd Department of Lung Diseases and Tuberculosis
Bialystok, Poland, 15-540
Actively Recruiting
26
John Paul II Specialist Hospital in Krakow
Krąków, Poland, 31-202
Actively Recruiting
27
Mandziuk Slawomir - Specialist Medical Practice
Lublin, Poland, 20-093
Actively Recruiting
28
Eugenia and Janusz Zeyland Wielkopolskie Centre of Pulmonology and Thoracic Surgery
Poznan, Poland, 60-569
Actively Recruiting
29
Specialist Hospital in Prabuty Sp. z o.o. (LLC)
Prabuty, Poland, 82-550
Actively Recruiting
30
Military Institute of Medicine - National Research Institute
Warsaw, Poland, 04-141
Actively Recruiting
Research Team
I
Innate Pharma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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