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).
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.
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.
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There are 30 Locations for this study
Saint Petersburg Florida, 33705, United States More Info
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Tampa Florida, 33612, United States More Info
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Chicago Illinois, 60637, United States More Info
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Lake Success New York, 11042, United States More Info
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Houston Texas, 77090, United States More Info
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Marseille , 13015, France More Info
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Rennes , 35033, France More Info
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Budapest , H-112, Hungary More Info
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Győr , 9024, Hungary More Info
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Szolnok , H-500, Hungary More Info
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Bialystok , 15-54, Poland More Info
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Krąków , 31-20, Poland More Info
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Lublin , 20-09, Poland More Info
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Poznań , 60-56, Poland More Info
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Prabuty , 82-55, Poland More Info
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Warsaw , 04-14, Poland More Info
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