EUCTR2017-001664-37-IT进行中（未招募）1 期
A randomized phase 2 study comparing immunotherapy with chemotherapy in the treatment of elderly patients with advanced NSCLC - MILES 5
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
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female ³ 70 years of age.
- •Histological documentation of primary squamous or non squamous non-small cell lung carcinoma.
- •Stage IV or IIIC disease with supraclavear metastatic nodes (according to TNM 8th edition).
- •PD-L1 expression in tumor cells (TC) = 25%* or unknown due to lack of tumor specimen (no more than 25% of the overall sample size will be allowed)
- •Clinical or radiologic evidence of disease (at least one measurable or non measurable lesion).
- •ECOG performance status 0 to 1.
- •Life expectancy > 3 months.
- •Adequate renal and hepatic function, defined as:
- •Total serum bilirubin = 1.5 institutional ULN.
- •AST and/or ALT = 2.5 x ULN for the institution (or = 5 x ULN if liver metastases are present)
- •Serum creatinine = 1.5 x ULN for the institution (or calculated creatinine clearance = 40 mL/min/1.73 m2).
- •Adequate bone marrow function, defined as:
- •Haemoglobin ³ 9.0 g/dL
- •Absolute Neutrophils count (ANC) ³ 1.5 x 109/L (> 1500 per mm3)
- •Platelet count ³ 100 x 109/L(>100,000 per mm3).
- •Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- •*Note: patients with PD-L1 TC = 50% should receive standard first-line pembrolizumab, if available in clinical practice. Therefore, their enrollment in the MILES-5 study is not encouraged.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •Cancer related
- •1.Activating epidermal growth factor receptor mutation (exon19 deletion or exon 21 L858R mutation or other activating/sensitizing mutations).
- •2.ALK or ROS1 positive (immunohistochemistry or FISH)
- •3.Mixed small-cell lung cancer and NSCLC histology.
- •Prior, current or planned treatment related
- •4.Prior chemotherapy or any other medical treatment for advanced NSCLC (previous neoadjuvant or adjuvant chemotherapy is allowed if > 6 months previously).
- •5.Prior exposure to immunomodulatory therapy, including, but not limited to, other anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies.
- •6.Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment ( corticosteroids at physiological doses not exceeding 10 mg/day of prednisone or an equivalent corticosteroid are allowed).
- •7.Any concurrent investigational product or other anticancer treatment.
- •Prior or concomitant conditions or procedures related
- •8.Active or prior documented autoimmune disease within the past 2 years (subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment within the past 2 years, are not excluded).
- •9.Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
- •10.History of allogeneic organ transplant
- •11.History of active primary immunodeficiency.
- •12.Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- •13.Receipt of live attenuated vaccine within 30 days prior to the first dose of study drugs.
- •14.Patients with previous malignancies in the last 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA)
- •15.Brain metastases or spinal cord compression, unless asymptomatic, previously treated, and stable off steroids and anti-convulsants for at least one month prior to study entry.
- •16.Leptomeningeal carcinomatosis
- •17.Clinically significant cardiovascular disease, including:
- •a.Myocardial infarction or unstable angina pectoris within < 6 months prior to the first study treatment
- •b.New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF)
- •c.Uncontrolled hypertension
- •d.Serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia)
- •e.Peripheral vascular disease > grade 3 (i.e. symptomatic and interfering with activities of daily living requiring repair or revision)
- •f.Mean QT interval corrected for heart rate (QTc) =470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia’s Correction.
- •18.Known hypersensitivity to any of the study drugs or excipients.
- •19.Evidence of any other concomitant illness, physical examination or laboratory findings (including but not limited to interstitial lung disease, active peptic ulcer disease or gast
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