Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05742607

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

Led by Innate Pharma · Updated on 2025-05-16

70

Participants Needed

30

Research Sites

166 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed and untreated patients with histologically or cytologically confirmed resectable NSCLC Stage IIA to IIIA
  • WHO Performance Status or ECOG of 0 or 1
  • Adequate organ and bone marrow function
  • Life expectancy of at least 12 weeks
  • Body weight greater than 35 kg
  • Females of childbearing potential must use effective contraception throughout the study
  • Negative pregnancy test for women of childbearing potential
  • Provision of tumor samples to confirm PD-L1, EGFR, or ALK status
  • Provision of tumor samples for exploratory biomarker analyses
  • Planned surgery must be lobectomy, sleeve resection, or bilobectomy as determined by the surgeon
  • Pre- or post-bronchodilator FEV1 of at least 1.0 L and DLCO greater than 40% predicted postoperatively
Not Eligible

You will not qualify if you...

  • Presence of sensitizing EGFR mutations or ALK translocations
  • History of allogeneic organ transplantation
  • Active or prior autoimmune or inflammatory disorders
  • Uncontrolled illness including hypertension, unstable angina, arrhythmia, active interstitial lung disease, serious gastrointestinal conditions, or psychiatric illness limiting compliance
  • History of thromboembolic events including stroke or unstable angina within 6 months
  • History of another primary cancer
  • Small-cell lung cancer or mixed small-cell lung cancer diagnosis
  • History of active primary immunodeficiency
  • Active infections including tuberculosis, hepatitis B, or hepatitis C (with exceptions)
  • Preoperative radiotherapy as part of care plan
  • Requirement for pneumonectomy, segmentectomy, or wedge resection surgery
  • QTc interval 470 ms or higher
  • Allergy or hypersensitivity to study drugs or excipients
  • Medical contraindications to chemotherapy
  • Moderate or severe cardiovascular disease
  • Concurrent cancer treatments excluding certain hormonal therapies
  • Receipt of live vaccines within 30 days before first study dose
  • Major surgery within 30 days before first study dose
  • Prior immune-mediated therapy exposure
  • Use of immunosuppressive medication within 14 days before first dose
  • Participation in other investigational studies within 30 days
  • Previous assignment to study drugs in this trial
  • Pregnancy, breastfeeding, or unwillingness to use birth control during and after study
  • Involvement in study planning or conduct
  • Investigator judgment deeming patient unlikely to comply
  • Exclusion criteria for optional genetics research component

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 30 locations

1

St. Anthony's Hospital - BayCare Health System

St. Petersburg, Florida, United States, 33705

Actively Recruiting

2

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States, 33612

Actively Recruiting

3

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Not Yet Recruiting

4

Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics

Lake Success, New York, United States, 11042

Not Yet Recruiting

5

Millennium Research & Clinical Development

Houston, Texas, United States, 77090

Actively Recruiting

6

UW Carbone Cancer Center - Cancer Connect

Madison, Wisconsin, United States, 53792

Actively Recruiting

7

Angers University Hospital Center

Angers, France, 49333

Actively Recruiting

8

University Hospital Center Caen

Caen, France, 14033

Actively Recruiting

9

Hospital Calmette

Lille, France, 59037

Not Yet Recruiting

10

CHU de Limoges

Limoges, France, 87042

Actively Recruiting

11

Leon Berard Center

Lyon, France, 69373

Actively Recruiting

12

Marseille University Hospital Center - North Hospital

Marseille, France, 13015

Actively Recruiting

13

Rennes University Hospital Center - Hospital Pontchaillou

Rennes, France, 35033

Actively Recruiting

14

Charles Nicolle Hospital

Rouen, France, 76031

Actively Recruiting

15

Gustave Roussy

Villejuif, France, 94805

Actively Recruiting

16

Henry Dunant Hospital Center

Athens, Greece, 11526

Actively Recruiting

17

University General Hospital "Attikon"

Athens, Greece, 12462

Actively Recruiting

18

University General Hospital of Ioannina

Ioannina, Greece, 45500

Actively Recruiting

19

University General Hospital of Patras

Pátrai, Greece, 26504

Actively Recruiting

20

Koranyi National Institute of Pulmonology, 14th Department of Pulmonology

Budapest, Hungary, H-1121

Actively Recruiting

21

Veszprem County Pulmonology Institute

Farkasgyepű, Hungary, 8582

Actively Recruiting

22

Petz Aladar University Teaching Hospital, Department of Pulmonology

Győr, Hungary, 9024

Actively Recruiting

23

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

Szolnok, Hungary, H-5000

Actively Recruiting

24

Pulmonology Institute Torokbalint

Törökbálint, Hungary, H-2045

Not Yet Recruiting

25

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

Bialystok, Poland, 15-540

Actively Recruiting

26

John Paul II Specialist Hospital in Krakow

Krąków, Poland, 31-202

Actively Recruiting

27

Mandziuk Slawomir - Specialist Medical Practice

Lublin, Poland, 20-093

Actively Recruiting

28

Eugenia and Janusz Zeyland Wielkopolskie Centre of Pulmonology and Thoracic Surgery

Poznan, Poland, 60-569

Actively Recruiting

29

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

Prabuty, Poland, 82-550

Actively Recruiting

30

Military Institute of Medicine - National Research Institute

Warsaw, Poland, 04-141

Actively Recruiting

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Research Team

I

Innate Pharma

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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