NL-OMON21412尚未招募不适用
ML41176 Unraveling tumor response and resistance to combined chemotherapy and PD-L1 inhibition with minimal invasive techniques in patients with advanced NSCLC with targetable disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
研究概览
简要总结
A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Provision of signed and dated, written informed consent.
- •2.Female and male subjects aged at least 18 years.
- •3.Subjects with histologically- or cytologically-documented non squamous NSCLC with a documented driver mutation (such as EGFR, ALK, ROS, BRAF, MET, RET, NTRK1-3, KRAS, NRG1)
- •4.New (< 3 month old) tumor specimen (histology or cytology containing enough tumor cells and tumor DNA for at least NGS and PD-L1 staining).
- •Confirmation of sufficient adequate tumor material by the central reviewing pathologist (Wim Timens) is required before start.
- •5.Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
- •6.Evidence of radiological disease progression following first line TKI or any subsequent treatment lines with TKI only (for EGFR treated with either osimertinib or failure of other TKIs 2nd line or later). Previous
- •course of chemotherapy is allowed, but not necessary as well.
- •7.ECOG performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
- •8.At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as = 10mm in the longest diameter (except for
- •pathological lymph nodes they must be = 15mm in short axis) with computerized tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements.
- •9.Adequate hematologic and end organ function, defined by the following laboratory results obtained within =14 days prior to study treatment:
- •-ANC =1500 cells/µL (without granulocyte colony-stimulating factor support)
- •-WBC counts >2500/µL
- •-Lymphocyte count =500/µL
- •-Platelet count =100,000/µL (without transfusion)
- •-Hemoglobin =9.0 g/dL. Patients may be transfused or receive erythropoietic treatment to meet this criterion.
- •-AST, ALT, and alkaline phosphatase = 2.5× the upper limit of normal (ULN), with the following exceptions:
- •-Patients with documented liver metastases: AST and/or ALT = 5 × ULN
- •-Patients with documented liver or bone metastases: alkaline phosphatase = 5 × ULN
- •-Serum bilirubin = 1.5 × ULN. Patients with known Gilbert disease who have serum bilirubin level = 3 × ULN may be enrolled.
- •-INR and aPTT = 1.5 × ULN. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
- •-Creatinine clearance = 30 mL/min.
- •10. Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of
- •non-child-bearing potential by fulfilling one of the following criteria at screening:
- •-Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.
- •-Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with Luteinizing Hormone
- •(LH) and Follicle-Stimulating Hormone (FSH) levels in the post-menopausal range for the institution.
- •-Documentation of irreversible surgical sterilization by hysterectomy, bilateral ophorectomy or bilateral salpingectomy but not tubal ligation.
- •11. Male subjects should be willing to use barrier contraception
排除标准
- •1.Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 14 days prior to inclusion of the study.
- •2.Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
- •-Patients who have had prior anti-CTLA-4 treatment may be enrolled, provided the following requirements are met:
- •-Minimum of 6 weeks from the last dose of anti-CTLA-4
- •-No history of severe immune related adverse effects from anti-CTLA-4 (CTCAE Grade 3 and 4).
- •3.CNS disease, treated brain metastases without the need for steroids are allowed.
- •4.Leptomeningeal disease.
- •5.Uncontrolled tumor-related pain.
- •-Patients requiring pain medication must be on a stable regimen at study entry.
- •-Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to enrollment. Patients should be recovered from the effects
- •of radiation. There is no required minimum recovery period.
- •-Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be
- •considered for loco-regional therapy if appropriate prior to enrollment.
- •6.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
- •7.Malignancies other than NSCLC within 3 years prior with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in
- •situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, ductal carcinoma in situ treated surgically with curative intent).
- •8.Pregnant and lactating women.
- •9.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
- •10.Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cell products or any component of the atezolizumab formulation.
- •11.History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular
- •thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- •-Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.
- •-Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
- •12.History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- •-History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- •13.Positive test for HIV.
- •14.Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C.
- •15.Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core a
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