Trial Title:
IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)
NCT ID:
NCT05742607
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Cisplatin
Carboplatin
Pemetrexed
Durvalumab
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Experimental: IPH5201 + durvalumab + 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
Intervention:
Intervention type:
Drug
Intervention name:
IPH5201 + durvalumab + standard chemotherapy
Description:
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.
Arm group label:
IPH5201 + durvalumab + standard chemotherapy
Other name:
Durvalumab
Other name:
MEDI4736, IMFINZI
Other name:
Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as chemotherapy
Other name:
Pemetrexed/Cisplatin Pemetrexed/Cisplatin as chemotherapy
Other name:
Pemetrexed/Carboplatin Pemetrexed/Carboplatin as chemotherapy
Summary:
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).
Detailed description:
This is an open-label, single-arm multicenter study. Eligible patients will be enrolled
and will receive IPH5201 + Durvalumab + standard of care chemotherapy before surgery
followed by IPH5201 + Durvalumab post-surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
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:
1. Participants with sensitising EGFR mutations or ALK translocations.
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.
26. Exclusion criteria for participation in the optional (DNA) genetics research
component.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Anthony's Hospital - BayCare Health System
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ahmad Shaker
Facility:
Name:
H. Lee Moffitt Cancer Center & Research Institute
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alberto Chiappori
Facility:
Name:
University of Chicago Medical Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Everett Vokes
Facility:
Name:
Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Nagashree Seetharamu
Facility:
Name:
Millennium Research & Clinical Development
Address:
City:
Houston
Zip:
77090
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anirudha Dasgupta
Facility:
Name:
UW Carbone Cancer Center - Cancer Connect
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vincent Ma
Phone:
800-622-8922
Email:
cancerconnect@uwcarbone.wisc.edu
Facility:
Name:
Angers University Hospital Center
Address:
City:
Angers
Zip:
49333
Country:
France
Status:
Recruiting
Contact:
Last name:
Jose Hureaux
Facility:
Name:
University Hospital Center Caen
Address:
City:
Caen
Zip:
14033
Country:
France
Status:
Recruiting
Contact:
Last name:
Simon Deshayes
Facility:
Name:
Hospital Calmette
Address:
City:
Lille
Zip:
59037
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Alexis Cortot
Facility:
Name:
CHU de Limoges
Address:
City:
Limoges
Zip:
87042
Country:
France
Status:
Recruiting
Contact:
Last name:
Thomas Egenod
Facility:
Name:
Leon Berard Center
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Contact:
Last name:
Maurice Perol
Facility:
Name:
Marseille University Hospital Center - North Hospital
Address:
City:
Marseille
Zip:
13015
Country:
France
Status:
Recruiting
Contact:
Last name:
Laurent Greillier
Facility:
Name:
Rennes University Hospital Center - Hospital Pontchaillou
Address:
City:
Rennes
Zip:
35033
Country:
France
Status:
Recruiting
Contact:
Last name:
Herve Lena
Facility:
Name:
Charles Nicolle Hospital
Address:
City:
Rouen
Zip:
76031
Country:
France
Status:
Recruiting
Contact:
Last name:
Florian Guisier
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Fabrice Barlesi
Facility:
Name:
Henry Dunant Hospital Center
Address:
City:
Athens
Zip:
11526
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Loannis Mountzios
Facility:
Name:
University General Hospital "Attikon"
Address:
City:
Athens
Zip:
12462
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Amanda Psyrri
Facility:
Name:
University General Hospital of Ioannina
Address:
City:
Ioánnina
Zip:
45500
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Mauri Davide
Facility:
Name:
University General Hospital of Patras
Address:
City:
Patras
Zip:
26504
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Angelos Koutras
Facility:
Name:
Koranyi National Institute of Pulmonology, 14th Department of Pulmonology
Address:
City:
Budapest
Zip:
H-1121
Country:
Hungary
Status:
Recruiting
Contact:
Last name:
Gabriella Temesi
Facility:
Name:
Veszprem County Pulmonology Institute
Address:
City:
Farkasgyepu
Zip:
8582
Country:
Hungary
Status:
Recruiting
Contact:
Last name:
Zsolt Kiraly
Facility:
Name:
Petz Aladar University Teaching Hospital, Department of Pulmonology
Address:
City:
Győr
Zip:
9024
Country:
Hungary
Status:
Recruiting
Contact:
Last name:
Zsuzsanna Szalai
Facility:
Name:
Jasz-Nagykun-Szolnok County Hetenyi Geza Hospital-Clinic, Department of Oncology
Address:
City:
Szolnok
Zip:
H-5000
Country:
Hungary
Status:
Recruiting
Contact:
Last name:
Tobor Csoszi
Facility:
Name:
Pulmonology Institute Torokbalint
Address:
City:
Torokbalint
Zip:
H-2045
Country:
Hungary
Status:
Not yet recruiting
Contact:
Last name:
Gabriella Galffy
Facility:
Name:
University Teaching Hospital in Bialystok, 2nd Department of Lung Diseases and Tuberculosis
Address:
City:
Bialystok
Zip:
15-540
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Robert Mroz
Facility:
Name:
John Paul II Specialist Hospital in Krakow
Address:
City:
Krąków
Zip:
31-202
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Jaroslaw Kuzdzal
Facility:
Name:
Mandziuk Slawomir - Specialist Medical Practice
Address:
City:
Lublin
Zip:
20-093
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Slawomir Mandziuk
Facility:
Name:
Eugenia and Janusz Zeyland Wielkopolskie Centre of Pulmonology and Thoracic Surgery
Address:
City:
Poznań
Zip:
60-569
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Katarzyna Stencel
Facility:
Name:
Specialist Hospital in Prabuty Sp. z o.o. (LLC)
Address:
City:
Prabuty
Zip:
82-550
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Anna Lowczak
Facility:
Name:
Military Institute of Medicine - National Research Institute
Address:
City:
Warsaw
Zip:
04-141
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Renata Duchnowska
Start date:
June 23, 2023
Completion date:
September 2026
Lead sponsor:
Agency:
Innate Pharma
Agency class:
Industry
Source:
Innate Pharma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05742607
