EUCTR2022-001903-42-PL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
适应症
相关药物
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
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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
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.
- •Page 12/101
- •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
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