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临床试验/EUCTR2022-001903-42-GR
EUCTR2022-001903-42-GR进行中（未招募）1 期

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 IIIA) Non-Small Cell Lung Cancer (MATISSE) - MATISSE

Innate Pharma SA0 个研究点目标入组 70 人开始时间: 2022年12月15日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
70
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •1.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.
  • •2.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.
  • •3.Patients must be = 18 years at the time of screening.
  • •4.Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC. Patients should have resectable (Stage IIA to Stage IIIA) disease (according to Version 8 of IASLC Staging Manual in Thoracic Oncology 2016. For patients with N2 disease, only those with 1 single nodal station = 3 cm are eligible) and be candidate for lobectomy, sleeve resection, or bilobectomy at the time of screening.
  • •5. WHO PS or ECOG PS of 0 or 1 at enrolment.
  • •6. Adequate organ and marrow function as defined below:
  • •Haemoglobin = 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 in 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 and Gault, 1976)
  • •(https://www.kidney.org/professionals/KDOQI/gfr_calculatorCoc).
  • •7. Must have a life expectancy of at least 12 weeks.
  • •8. Body Weight > 35 kg.
  • •9. Male and/or female.
  • •10. Negative pregnancy test (serum or urine) for women of
  • •childbearing potential.
  • •11. Provision of tumor samples (newly acquired [preferred] or archival tumor tissue [= 6 months old]) to confirm PD-L1 status, EGFR, or ALK status where required during screening and prior to nC1D1.
  • •Provision of tumor samples appropriate for exploratory biomarker analyses.
  • •13. Patients will be suitable for inclusion if the planned surgery to be performed will be lobectomy, sleeve
  • •resection, or bilobectomy, as determined by the attending surgeon based on the baseline findings.
  • •Patients whose planned surgery at enrolment includes pneumonectomy, segmentectomies, or
  • •wedge resections are not eligible for this study.
  • •14. A pre- or post-bronchodilator FEV1 of 1.0 L and 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 ESMO guidelines on pre-treatment risk assessment. Both an FEV1 and a DLCO test are required for assessing lung function at screening.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 70
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range 0

排除标准

  • •1.Patients with sensitizing EGFR mutations or ALK translocations.
  • •2.History of allogeneic organ transplantation.
  • •3.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.
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  • •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.
  • •4. 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 diarrhoea, 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.
  • •5. 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.
  • •6. 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.
  • •6. Patients with small-cell lung cancer or mixed small-cell lung cancer.
  • •7. History of active primary immunodeficiency.
  • •8. 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.
  • •9. Patients who have preoperative radiotherapy treatment as part of their care plan.
  • •10. Patients who require or may require pneumonectomy, segmentectomies, or wedge resections, as
  • •assessed by their surgeon, to obtain potentially curative resection of primary tumor.
  • •11. 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).
  • •12. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • •13. Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
  • •14. 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.
  • •NYHA Class 3 or 4 congestive heart failure, or uncontrolled hyperte

研究者

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