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) - MATISSE

Innate Pharma SA0 sites70 target enrollmentDecember 15, 2022

Overview

No summary available.

Registry

who.int

Start Date

December 15, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
•2\.Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses – including collection of samples for genetic analysis, if applicable.
•3\.Patients must be \= 18 years at the time of screening.
•4\.Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC. Patients should have resectable (Stage IIA to Stage IIIA) disease (according to Version 8 of IASLC Staging Manual in Thoracic Oncology 2016\. For patients with N2 disease, only those with 1 single nodal station \= 3 cm are eligible) and be candidate for lobectomy, sleeve resection, or bilobectomy at the time of screening.
•5\. WHO PS or ECOG PS of 0 or 1 at enrolment.
•6\. Adequate organ and marrow function as defined below:
•Haemoglobin \= 9\.0 g/dL.
•Absolute neutrophil count (ANC) \= 1\.5 × 109/L.
•Platelet count \= 100 × 109/L.
•Serum bilirubin \= 1\.5 × Upper limit of normal (ULN). This will not apply to patients with

•1\.Patients with sensitizing EGFR mutations or ALK translocations.
•2\.History of allogeneic organ transplantation.
•3\.Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn’s disease], diverticulitis \[with the exception of diverticulosis], systemic
•lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[e.g., granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, or uveitis]). The following are exceptions to this criterion:
•Patients with vitiligo or alopecia.
•Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone
•replacement.
•Any chronic skin condition that does not require systemic therapy.
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•Patients without active disease in the last 5 years may be included but only after consultation