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New treatment option for Non Small Cell Lung Cancer
Official title IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)
ClinicalTrials.gov ID: NCT05742607
What this study is testing
What is IPH5201 + durvalumab + standard chemotherapy?
IPH5201 + durvalumab + standard chemotherapy is an investigational medicine, being studied as a potential treatment for non small cell lung cancer.
Also referred to as Durvalumab, MEDI4736, IMFINZI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)...
- Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses - including collection of samples...
- 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...
You likely can't join if
- 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]...
- Patients with vitiligo or alopecia.
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Lake Success, New York, United States
- Houston, Texas, United States
- Madison, Wisconsin, United States
- Angers, France
- Caen, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Rennes, France
- Rouen, France
- Villejuif, France
- Athens, Greece
- Ioannina, Greece
- Pátrai, Greece
- Budapest, Hungary
- Farkasgyepű, Hungary
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St. Petersburg, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Lake Success, New York, United States; Houston, Texas, United States; Madison, Wisconsin, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.