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

NCT05742607 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IPH5201-201
• Study Type: interventional
• Target: 70
• Locations: 5 countries
• Sites: 30

Brief 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).

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Pathological Complete Response (pCR)

  Number of patients with pathological Complete Response (pCR)

  16 weeks after the first dose of study intervention.

• Adverse events (AEs) and serious adverse events (SAEs)

  Number of patients with adverse events (AEs) and serious adverse events (SAEs).

  Until Day 90 after the last dose of study interventions.

Secondary Outcomes (8)

• Event-Free Survival (EFS)

  Up to approximately 2 years.

• Disease Free Survival (DFS)

  Up to approximately 2 years.

• Surgical resection

  Approximately 16 weeks after the first dose of study intervention.

• Major Pathological Response (mPR)

  Approximately 16 weeks after the first dose of study intervention.

• Objective Response Rate (ORR)

  Up to approximately 4 months adjuvant.

Study Arms (1)

IPH5201 + durvalumab + standard chemotherapy

EXPERIMENTAL

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.

Drug: IPH5201 + durvalumab + standard chemotherapy

Interventions

IPH5201 + durvalumab + standard chemotherapy DRUG

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.

Also known as: Durvalumab, MEDI4736, IMFINZI, Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as chemotherapy, Pemetrexed/Cisplatin Pemetrexed/Cisplatin as chemotherapy, Pemetrexed/Carboplatin Pemetrexed/Carboplatin as chemotherapy

IPH5201 + durvalumab + standard chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Must have a life expectancy of at least 12 weeks.
• Body weight \> 35 kg.
• Females of childbearing potential should use an acceptable method of contraception from the time of screening throughout the total duration of the study.
• Negative pregnancy test (serum or urine) for women of childbearing potential.
• 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.
• Provision of tumor samples appropriate for exploratory biomarker analyses.
• A pre- or post-bronchodilator FEV1 of 1.0 L and DLCO \> 40% postoperative predicted value.

You may not qualify if:

• 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 any grade of venous or arterial thromboembolic events including cerebrovascular accident, transient ischemic attack, or unstable angina pectoris within 6 months prior to enrollment.
• History of another primary malignancy.
• Patients with small-cell lung cancer or mixed small-cell lung cancer.
• History of active primary immunodeficiency.
• 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.
• Patients who have preoperative radiotherapy treatment as part of their care plan.
• Patients who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon, to obtain potentially curative resection of primary tumor.
• 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).
• Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
• Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
• Patients with moderate or severe cardiovascular disease.

Sponsors & Collaborators

• Innate Pharma: lead

Study Sites (30)

St. Anthony's Hospital - BayCare Health System

St. Petersburg, Florida, 33705, United States

RECRUITING

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics

Lake Success, New York, 11042, United States

NOT YET RECRUITING

Millennium Research & Clinical Development

Houston, Texas, 77090, United States

RECRUITING

UW Carbone Cancer Center - Cancer Connect

Madison, Wisconsin, 53792, United States

RECRUITING

Angers University Hospital Center

Angers, 49333, France

RECRUITING

University Hospital Center Caen

Caen, 14033, France

RECRUITING

Hospital Calmette

Lille, 59037, France

NOT YET RECRUITING

CHU de Limoges

Limoges, 87042, France

RECRUITING

Leon Berard Center

Lyon, 69373, France

RECRUITING

Marseille University Hospital Center - North Hospital

Marseille, 13015, France

RECRUITING

Rennes University Hospital Center - Hospital Pontchaillou

Rennes, 35033, France

RECRUITING

Charles Nicolle Hospital

Rouen, 76031, France

RECRUITING

Gustave Roussy

Villejuif, 94805, France

RECRUITING

Henry Dunant Hospital Center

Athens, 11526, Greece

RECRUITING

University General Hospital "Attikon"

Athens, 12462, Greece

RECRUITING

University General Hospital of Ioannina

Ioannina, 45500, Greece

RECRUITING

University General Hospital of Patras

Pátrai, 26504, Greece

RECRUITING

Koranyi National Institute of Pulmonology, 14th Department of Pulmonology

Budapest, H-1121, Hungary

RECRUITING

Veszprem County Pulmonology Institute

Farkasgyepű, 8582, Hungary

RECRUITING

Petz Aladar University Teaching Hospital, Department of Pulmonology

Győr, 9024, Hungary

RECRUITING

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

Szolnok, H-5000, Hungary

RECRUITING

Pulmonology Institute Torokbalint

Törökbálint, H-2045, Hungary

NOT YET RECRUITING

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

Bialystok, 15-540, Poland

RECRUITING

John Paul II Specialist Hospital in Krakow

Krąków, 31-202, Poland

RECRUITING

Mandziuk Slawomir - Specialist Medical Practice

Lublin, 20-093, Poland

RECRUITING

Eugenia and Janusz Zeyland Wielkopolskie Centre of Pulmonology and Thoracic Surgery

Poznan, 60-569, Poland

RECRUITING

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

Prabuty, 82-550, Poland

RECRUITING

Military Institute of Medicine - National Research Institute

Warsaw, 04-141, Poland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab; Carboplatin; Pemetrexed; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Therapeutics

Central Study Contacts

Innate Pharma

CONTACT

+33484903084; clinical.trials@innate-pharma.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 24, 2023
• Study Start: June 23, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

GR (4); US (6); HU (5); PL (6); FR (9)