Lung Cancer Clinical Trial

IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)

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).

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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.
Provision of tumor samples (newly acquired [preferred] or archival tumor tissue [≤ 6 months old]) to confirm Programmed Death-Ligand 1 status, Estimated Glomerular Filtration Rate, or Anaplastic Lymphoma Kinase status.
Adequate pulmonary function

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 another primary malignancy.
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 another primary malignancy.
Participants with small-cell lung cancer or mixed small-cell lung cancer.
History of active primary immunodeficiency.
Participants who have preoperative radiotherapy treatment as part of their care plan.
Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour.
QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.
Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
Participants with moderate or severe cardiovascular disease.
Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.
Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.
Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A and HLA-E agents are also excluded.
Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.
Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions
Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A and HLA-E agents are also excluded.
Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT05742607

Recruitment Status:

Recruiting

Sponsor:

Innate Pharma

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There are 24 Locations for this study

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H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States More Info
Alberto Chiappori
Contact
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States More Info
Hiran Fernando
Contact
Angers University Hospital Center
Angers , 49333, France More Info
Jose Hureaux
Contact
CHU de Limoges
Limoges , 87042, France More Info
Thomas Igneod
Contact
Leon Berard Center
Lyon , 69373, France More Info
Maurice Perol
Contact
Marseille University Hospital Center - North Hospital
Marseille , 13015, France More Info
Laurent Greillier
Contact
Curie Institute
Paris , 75248, France More Info
Catherine Daniel
Contact
Rennes University Hospital Center - Hospital Pontchaillou
Rennes , 35033, France More Info
Herve Lena
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Charles Nicolle Hospital
Rouen , 76031, France More Info
Florian Guisier
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Gustave Roussy
Villejuif , 94805, France More Info
Fabrice Barlesi
Contact
Henry Dunant Hospital Center
Athens , 11526, Greece More Info
Loannis Mountzios
Contact
University General Hospital "Attikon"
Athens , 12462, Greece More Info
Amanda Psyrri
Contact
University General Hospital of Ioannina
Ioánnina , 45500, Greece More Info
Mauri Davide
Contact
University General Hospital of Patras
Patras , 26504, Greece More Info
Angelos Koutras
Contact
Koranyi National Institute of Pulmonology, 14th Department of Pulmonology
Budapest , H-112, Hungary More Info
Gabriella Temesi
Contact
Veszprem County Pulmonology Institute
Farkasgyepu , 8582, Hungary More Info
Zsolt Kiraly
Contact
Petz Aladar University Teaching Hospital, Department of Pulmonology
Győr , 9024, Hungary More Info
Zsuzsanna Szalai
Contact
Jasz-Nagykun-Szolnok County Hetenyi Geza Hospital-Clinic, Department of Oncology
Szolnok , H-500, Hungary More Info
Tobor Csoszi
Contact
Pulmonology Institute Torokbalint
Torokbalint , H-204, Hungary More Info
Gabriella Galffy
Contact
University Teaching Hospital in Bialystok, 2nd Department of Lung Diseases and Tuberculosis
Bialystok , 15-54, Poland More Info
Robert Mroz
Contact
John Paul II Specialist Hospital in Krakow
Krąków , 31-20, Poland More Info
Jaroslaw Kuzdzal
Contact
Mandziuk Slawomir - Specialist Medical Practice
Lublin , 20-09, Poland More Info
Slawomir Mandziuk
Contact
Specialist Hospital in Prabuty Sp. z o.o. (LLC)
Prabuty , 82-55, Poland More Info
Anna Lowczak
Contact
Military Institute of Medicine - National Research Institute
Warsaw , 04-14, Poland More Info
Renata Duchnowska
Contact

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT05742607

Recruitment Status:

Recruiting

Sponsor:


Innate Pharma

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