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

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

Conditions

Non Small Cell Lung Cancer

Keywords

NSCL; neoadjuvant; adjuvant; perioperative

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. In Cohort 1 only, 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. In Cohort 1 only, 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:

• Patients are eligible to be included in the study only if all of the following criteria apply:
• 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.
• 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.
• Patients must be ≥18 years at the time of screening.
• Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC. Patients should have resectable disease (Stage IIA to Stage IIIA; Stage IIIB - Nodal stage N2 after the first 40 patients \[cohort 2\]), according to Version 8 of IASLC Staging Manual in Thoracic Oncology (2016), and be candidates for lobectomy, sleeve resection, or bilobectomy at the time of screening. For patients with N2 disease, only those with 1 single nodal station ≤3 cm are eligible (only valid for Cohort 1).
• At screening, complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his/her practice.
• T4 tumors will only be eligible if they are defined as T4 based only on their size (more than 7 cm); any other reason for T4 (e.g., adherent to any of the following structures: diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina) will be considered ineligible.
• Nodal status should be investigated with whole-body fluorodeoxyglucose-positron emission tomography (FDG-PET), plus contrast-enhanced CT. If PET/CT scan is positive in the mediastinum, or if the scan is negative but there is T \>3 cm, central tumor, or cN1, then it is recommended that nodal status be proven by biopsy via endobronchial ultrasound, mediastinoscopy, or thoracoscopy.
• WHO Performance Status (WHO PS) score or Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 at enrollment.
• Adequate organ and marrow function as defined below:
• Hemoglobin ≥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 confirmed Gilbert's syndrome, who will be allowed upon consultation with their physician.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.

You may not qualify if:

• Patients with sensitizing EGFR mutations or ALK translocations.
• History of allogeneic organ transplantation.
• 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.
• Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician/Medical Scientist.
• Patients with celiac disease controlled by diet alone.
• Uncontrolled intercurrent illness, including but not limited to, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
• 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, except for the following:
• Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drugs and of low potential risk for recurrence.
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• Adequately treated carcinoma in-situ without evidence of disease.
• Patients with small-cell lung cancer or mixed small-cell lung cancer.

Sponsors & Collaborators

• Innate Pharma: lead

Study Sites (30)

St. Anthony's Hospital - BayCare Health System

St. Petersburg, Florida, 33705, United States

TERMINATED

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

TERMINATED

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

WITHDRAWN

Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics

Lake Success, New York, 11042, United States

WITHDRAWN

Millennium Research & Clinical Development

Houston, Texas, 77090, United States

TERMINATED

UW Carbone Cancer Center - Cancer Connect

Madison, Wisconsin, 53792, United States

TERMINATED

Angers University Hospital Center

Angers, 49333, France

TERMINATED

University Hospital Center Caen

Caen, 14033, France

TERMINATED

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

TERMINATED

Gustave Roussy

Villejuif, 94805, France

RECRUITING

Henry Dunant Hospital Center

Athens, 11526, Greece

WITHDRAWN

University General Hospital "Attikon"

Athens, 12462, Greece

RECRUITING

University General Hospital of Ioannina

Ioannina, 45500, Greece

TERMINATED

University General Hospital of Patras

Pátrai, 26504, Greece

TERMINATED

Koranyi National Institute of Pulmonology, 14th Department of Pulmonology

Budapest, H-1121, Hungary

RECRUITING

Veszprem County Pulmonology Institute

Farkasgyepű, 8582, Hungary

TERMINATED

Petz Aladar University Teaching Hospital, Department of Pulmonology

Győr, 9024, Hungary

TERMINATED

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

TERMINATED

Mandziuk Slawomir - Specialist Medical Practice

Lublin, 20-093, Poland

TERMINATED

Eugenia and Janusz Zeyland Wielkopolskie Centre of Pulmonology and Thoracic Surgery

Poznan, 60-569, Poland

TERMINATED

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

TERMINATED

Related Publications (1)

• https://aacrjournals.org/cancerres/article/86/8_Supplement/CT231/783296/Abstract-CT231-Dual-CD39-and-PD-L1-inhibition

  RESULT

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 Cohort 1: 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. Cohort 2: Patients PD-L1 ≥1% will receive neoadjuvant therapy with IPH5201+durvalumab, in addition to standard chemotherapy.
• 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 (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

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