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Non Small Cell Lung CancerPhase 2NCT05742607

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

A Phase 2 study testing IPH5201 + durvalumab + standard chemotherapy in people with Non Small Cell Lung Cancer, run by Innate Pharma at 30 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
IPH5201 + durvalumab + standard chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
30 sitesin 5 countries
Study dates
23 Jun 2023to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Measured creatinine clearance (CrCL) >40 mL/min or calculated CrCL >40 mL/min as determined by Cockcroft-Gault formula using actual body weight (Cockroft-Gault, 1976) (https://www.kidney.org/professionals/KDOQI/gfr_calculatorCoc).
  • Must have a life expectancy of at least 12 weeks.
  • Body weight >35 kg.
  • Male or female. Women of childbearing potential should use an acceptable method of contraception from the time of screening throughout the total duration of the study, and (for drugs that are potentially genotoxic) the drug washout period (180 days after the last dose of study drugs) to prevent pregnancy.
  • A non-sterilized male partner of a woman of childbearing potential must use a male condom plus spermicide (or condom alone in countries where spermicides are not approved) throughout this period. Male patients who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception (from the time of screening throughout the total duration of the study and (for drugs that are potentially genotoxic) the drug washout period (180 days after the last dose of study drugs) to prevent pregnancy in a partner. Male patients must not donate or bank sperm during this same time period. For more details on contraceptive guidance of the study for both women of childbearing potential and non sterilized male patients.
  • 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 PD-L1 status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status, where required during screening and prior to nC1D1.
  • PD-L1 status: (i) If the patient's PD-L1 status has already been assessed using the analytically validated Ventana PD-L1 (SP263) immunohistochemistry (IHC) assay, 22C3 PharmDx assay, or 28-8 PharmDx assay, this test result can be used. (ii) Local laboratory results can be used if performed using the analytically validated Ventana PD-L1 (SP263) IHC assay, 22C3 PharmDx assay, or 28-8 PharmDx assay (iii) If appropriate local testing and/or previous results are not available, PD-L1 testing using the Ventana PD-L1 (SP263) IHC assay will be performed centrally using either newly acquired tumor tissue (preferred) or archival tissue (≤6 months old). Note: For Cohort 2 (PD-L1-positive cohort), only patients with PD-L1 expression tumor proportion score (TPS) ≥1% will be enrolled. (b) ALK and EGFR status: (i) Local laboratory results for ALK and EGFR will be obtained using a well validated, local-regulatory-approved assay. Neither patients with EGFR/ALK mutations nor those with unknown EGFR/ALK status will be enrolled, with the following exceptions:
  • Patients with documented Kirsten rat sarcoma virus (KRAS) mutations do not require EGFR/ALK status.
  • Patients with squamous cell carcinoma do not require ALK status.
  • Provision of tumor samples appropriate for exploratory biomarker analyses
  • Patients are suitable for inclusion if the planned surgery is lobectomy, sleeve resection, or bilobectomy, as determined by the attending surgeon based on the baseline findings. Patients whose planned surgery at enrollment includes pneumonectomy, segmentectomies, or wedge resections are not eligible for this study.
  • A pre- or post-bronchodilator forced expiratory volume (FEV1) of 1.0 L and diffusing capacity of lung for carbon monoxide (DLCO) >40% postoperative predicted value. Use of these cut-off values to assess candidacy for resection should be guided by the results of cardiopulmonary exercise testing as outlined in the European Society for Medical Oncology (ESMO) guidelines on pre-treatment risk assessment. Both an FEV1 and a DLCO test are required for assessing lung function at screening.

Who cannot join

  • Patients meeting any of the following exclusion criteria will not be eligible to participate in the study:
  • 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.
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  • 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.
  • 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 hepatitis B surface antigen [HBsAg] result) and hepatitis C virus (HCV). Patients with a past or resolved hepatitis B virus (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 the polymerase chain reaction test 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 electrocardiograms [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:
  • Presence of cardiac disease, including myocardial infarction or unstable angina pectoris within 6 months prior to study entry.
  • New York Heart Association (NYHA) Class III or IV congestive heart failure, or uncontrolled hypertension.
  • History of hypertensive crisis/hypertensive encephalopathy within 6 months prior to the scheduled first dose of study drugs.
  • Any concurrent chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment. However, concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of study drugs. Note: If enrolled, patients should not be administered live vaccine while receiving study drugs and up to 30 days after the last dose of study drugs.
  • Major surgical procedure (as defined by the Investigator) within 30 days prior to the first dose of study drugs.
  • Prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Patients who received agents targeting the adenosine pathway (e.g., anti-CD73 antibody, adenosine A2A receptor [A2AR] inhibitor, anti-CD39 antibody) are also excluded.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection)
  • Systemic corticosteroids ≤12 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • Participation in another clinical study with an investigational product administered within 30 days prior to enrollment.
  • Previous study drugs (durvalumab, IPH5201) assignment in the present study. Other Exclusions
  • Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of study drugs administration.
  • Involvement in the planning and/or conduct of the study (applies to both company staff and/or staff at the study site).
  • Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
  • Exclusion criteria for participation in the optional (DNA) genetics research component of the study include the following:
  • Previous allogeneic bone marrow transplant
  • Non-leukocyte-depleted whole blood transfusion within 120 days before genetic sample collection.
  • Only for patients in Cohort 2: Patients with PD-L1 expression TPS <1% or unknown PD-L1 status.

Trial locations and contacts

30 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Innate Pharma contact

+33484903084

clinical.trials@innate-pharma.fr

30 sites in 5 countries

France9 sites, 6 recruiting

  • Angers University Hospital Center

    Angers, 49333

    Terminated

  • University Hospital Center Caen

    Caen, 14033

    Terminated

  • Hospital Calmette

    Lille, 59037

    Alexis Cortot

    Not yet recruiting

  • CHU de Limoges

    Limoges, 87042

    Thomas Egenod

    Recruiting

  • Leon Berard Center

    Lyon, 69373

    Maurice Perol

    Recruiting

  • Marseille University Hospital Center - North Hospital

    Marseille, 13015

    Laurent Greillier

    Recruiting

  • Rennes University Hospital Center - Hospital Pontchaillou

    Rennes, 35033

    Herve Lena

    Recruiting

  • Charles Nicolle Hospital

    Rouen, 76031

    Terminated

  • Gustave Roussy

    Villejuif, 94805

    Fabrice Barlesi

    Recruiting

Other trials in France

United States6 sites

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Withdrawn

  • Millennium Research & Clinical Development

    Houston, Texas, 77090

    Terminated

  • Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics

    Lake Success, New York, 11042

    Withdrawn

  • UW Carbone Cancer Center - Cancer Connect

    Madison, Wisconsin, 53792

    Terminated

  • St. Anthony's Hospital - BayCare Health System

    St. Petersburg, Florida, 33705

    Terminated

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

    Terminated

Other trials in United States

Poland6 sites, 2 recruiting

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

    Bialystok, 15-540

    Robert Mroz

    Recruiting

  • John Paul II Specialist Hospital in Krakow

    Krąków, 31-202

    Terminated

  • Mandziuk Slawomir - Specialist Medical Practice

    Lublin, 20-093

    Terminated

  • Eugenia and Janusz Zeyland Wielkopolskie Centre of Pulmonology and Thoracic Surgery

    Poznan, 60-569

    Terminated

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

    Prabuty, 82-550

    Anna Lowczak

    Recruiting

  • Military Institute of Medicine - National Research Institute

    Warsaw, 04-141

    Terminated

Other trials in Poland

Hungary5 sites, 3 recruiting

  • Koranyi National Institute of Pulmonology, 14th Department of Pulmonology

    Budapest, H-1121

    Gabriella Temesi

    Recruiting

  • Veszprem County Pulmonology Institute

    Farkasgyepű, 8582

    Terminated

  • Petz Aladar University Teaching Hospital, Department of Pulmonology

    Győr, 9024

    Terminated

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

    Szolnok, H-5000

    Lengyel

    Recruiting

  • Pulmonology Institute Torokbalint

    Törökbálint, H-2045

    Gabriella Galffy

    Not yet recruiting

Other trials in Hungary

Greece4 sites, 1 recruiting

  • Henry Dunant Hospital Center

    Athens, 11526

    Withdrawn

  • University General Hospital "Attikon"

    Athens, 12462

    Amanda Psyrri

    Recruiting

  • University General Hospital of Ioannina

    Ioannina, 45500

    Terminated

  • University General Hospital of Patras

    Pátrai, 26504

    Terminated

Other trials in Greece

About this study

Official title: 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)

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

Read the detailed description

Currently enrolling in Cohort 2: this is an open-label, single-arm multicenter study. Eligible NSCLC patients PD-L1 ≥1% will be enrolled and will receive IPH5201 + Durvalumab + standard of care chemotherapy before surgery.

Being tested
IPH5201 + durvalumab + standard chemotherapy
Keywords
NSCL, neoadjuvant, adjuvant, perioperative
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPH5201 + durvalumab + standard chemotherapyDrug

    Also called Durvalumab, MEDI4736, IMFINZI, Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as chemotherapy, Pemetrexed/Cisplatin Pemetrexed/Cisplatin as 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.

Study groups in NCT05742607
Study groupRoleWhat they receive
IPH5201 + durvalumab + standard chemotherapyExperimentalPatients 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.
Receives: Drug: IPH5201 + durvalumab + standard chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Response (pCR)

    Number of patients with pathological Complete Response (pCR)

    Measured: 16 weeks after the first dose of study intervention.

  2. Adverse events (AEs) and serious adverse events (SAEs)

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

    Measured: Until Day 90 after the last dose of study interventions.

Secondary outcomes (8)

  1. Event-Free Survival (EFS)

    Number of patients experiencing an Event-Free Survival (EFS) event.

    Measured: Up to approximately 2 years.

  2. Disease Free Survival (DFS)

    Number of patients experiencing a Disease Free Survival (DFS) event (event from surgery onwards).

    Measured: Up to approximately 2 years.

  3. Surgical resection

    Number of participants having surgical resection.

    Measured: Approximately 16 weeks after the first dose of study intervention.

  4. Major Pathological Response (mPR)

    Number of patients with a major Pathological Response (mPR).

    Measured: Approximately 16 weeks after the first dose of study intervention.

  5. Objective Response Rate (ORR)

    Number of patients with an Objective Response Rate (ORR).

    Measured: Up to approximately 4 months adjuvant.

  6. Overall Survival (OS)

    Overall Survival (OS).

    Measured: Up to approximately 2 years.

  7. PK of IPH5201 in combination with durvalumab +/- chemotherapy

    Serum concentration (PK) of IPH5201 in combination with durvalumab +/- chemotherapy, in patients receiving neoadjuvant and adjuvant treatment.

    Measured: Up to approximately 4 months adjuvant.

  8. Anti-study drug antibodies (ADA)

    Number of patients with anti-study drug antibodies (ADA).

    Measured: Up to approximately 4 months adjuvant.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study start23 Jun 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05742607
Sponsor's protocol ID
IPH5201-201
Status last verified
Jun 2026
First submitted
15 Feb 2023
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IPH5201 + durvalumab + standard chemotherapy in people with Non Small Cell Lung Cancer, run by Innate Pharma at 30 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in France, United States, Poland, Hungary, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Innate Pharma (+33484903084, clinical.trials@innate-pharma.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (pCR) (time frame: 16 weeks after the first dose of study intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05742607, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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