NL-OMON54889招募中不适用
nraveling tumor response and resistance to combined chemotherapy and PD-L1 inhibition with minimal invasive techniques in patients with advanced NSCLC with targetable disease - Biomarker by minimal invasive techniques of response to chemo-immunotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
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, HER 2).
- •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 confirmed by a
- •pathologist). If the tumor specimen reveals a possible new targetable driver
- •than that has to be discussed with the subject as an option next to this study.
- •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:
- •o ANC >=1500 cells/µL (without granulocyte colony-stimulating factor support)
- •o WBC counts >2500/µL
- •o Lymphocyte count >=500/µL
- •o Platelet count >=100,000/µL (without transfusion)
- •o Hemoglobin >=9.0 g/dL. Patients may be transfused or receive erythropoietic
- •treatment to meet this criterion.
- •o 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 ×
- •o Serum bilirubin <= 1.5 × ULN. Patients with known Gilbert disease who have
- •serum bilirubin level <= 3 × ULN may be enrolled.
- •o 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.
- •o 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:
- •o Post-menopausal defined as aged more than 50 years and amenorrhoeic for at
- •least 12 months following cessation of all exogenous hormonal treatments.
- •o 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.
- 另有 1 项未显示
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
- •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:
- •o Minimum of 6 weeks from the last dose of anti*CTLA-4
- •o 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
- •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
- •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
- •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)
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