RecruitingPhase 2NCT05742607

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

Official Title: 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 III) Non-Small Cell Lung CancEr (MATISSE)

Sponsor

Innate Pharma

Enrollment

70 participants

Start Date

Jun 23, 2023

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

In Cohort 1, the study was intended to assess 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). Study Design was updated following the results of interim analysis # 2 (protocol amendment, adding cohort 2). Cohort 2 includes patients with resectable Stage II to IIIB NSCLC expressing PD-L1 ≥1%, receiving (only) neoadjuvant IPH5201+ durvalumab + chemotherapy

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two immunotherapy drugs — IPH5201 (a drug that blocks a signal that helps tumors hide from the immune system) and durvalumab (an immune checkpoint inhibitor) — given before surgery can shrink non-small cell lung cancer (NSCLC) and improve surgical outcomes. **You may be eligible if...** - You have newly diagnosed, previously untreated non-small cell lung cancer at a resectable stage (Stage IIA to IIIA) - Your general health is good (ECOG/WHO performance status 0–1) - Your lung function is adequate (FEV1 ≥ 1.0 L and DLCO >40%) - You weigh more than 35 kg - Your planned surgery is a lobectomy, sleeve resection, or bilobectomy - You are able to use contraception (if applicable) **You may NOT be eligible if...** - Your tumor has specific genetic mutations (EGFR mutations or ALK rearrangements), which respond better to targeted therapies - You have had an organ transplant, active autoimmune disease, or active infections - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIPH5201 + durvalumab + standard chemotherapy

Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy. In Cohort 1 only, Following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab.

Locations(30)

St. Anthony's Hospital - BayCare Health System

St. Petersburg, Florida, United States

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics

Lake Success, New York, United States

Millennium Research & Clinical Development

Houston, Texas, United States

UW Carbone Cancer Center - Cancer Connect

Madison, Wisconsin, United States

Angers University Hospital Center

Angers, France

University Hospital Center Caen

Caen, France

Hospital Calmette

Lille, France

CHU de Limoges

Limoges, France

Leon Berard Center

Lyon, France

Marseille University Hospital Center - North Hospital

Marseille, France

Rennes University Hospital Center - Hospital Pontchaillou

Rennes, France

Charles Nicolle Hospital

Rouen, France

Gustave Roussy

Villejuif, France

Henry Dunant Hospital Center

Athens, Greece

University General Hospital "Attikon"

Athens, Greece

University General Hospital of Ioannina

Ioannina, Greece

University General Hospital of Patras

Pátrai, Greece

Koranyi National Institute of Pulmonology, 14th Department of Pulmonology

Budapest, Hungary

Veszprem County Pulmonology Institute

Farkasgyepű, Hungary

Petz Aladar University Teaching Hospital, Department of Pulmonology

Győr, Hungary

Jasz-Nagykun-Szolnok County Hetenyi Geza Hospital-Clinic, Department of Oncology

Szolnok, Hungary

Pulmonology Institute Torokbalint

Törökbálint, Hungary

University Teaching Hospital in Bialystok, 2nd Department of Lung Diseases and Tuberculosis

Bialystok, Poland

John Paul II Specialist Hospital in Krakow

Krąków, Poland

Mandziuk Slawomir - Specialist Medical Practice

Lublin, Poland

Eugenia and Janusz Zeyland Wielkopolskie Centre of Pulmonology and Thoracic Surgery

Poznan, Poland

Specialist Hospital in Prabuty Sp. z o.o. (LLC)

Prabuty, Poland

Military Institute of Medicine - National Research Institute

Warsaw, Poland

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NCT05742607

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