A phase II single-arm trial evaluating safety and efficacy of Durvalumab in ECOG Performance Status 2-3, treatment-naive, patients with stage IV Non-Small Cell Lung Cancer (NSCLC) and high PD-L1 tumor expression

IFCT0 个研究点目标入组 67 人开始时间: 2019年4月9日最近更新: 2024年9月2日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 67

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•1.Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
•Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
•2.Histologically or cytologically-proven NSCLC (squamous or non-squamous).
•If the diagnosis is cytologically-proven, sufficient material is necessary with at least 100 tumor cells evaluated for PD-L1 IHC.
•3.PD-L1 expression =25% of tumor cells as assessed by the local pathology laboratory using protocols validated.
•4.Available tumor samples for centralized PD-L1 immunohistochemistry analysis.
•5.No EGFR mutation and no ALK gene rearrangement.
•6.Stage IV (8th classification TNM) M1a or M1b or M1c with 3 or lower of metastatic organ sites on PET-CT. Multiple lesions in a single organ are considered as one metastatic organ site. Any positive distant (non regional) lymph nodes were counted collectively as one metastatic organ site.
•7.ECOG PS= 2 (in the first step) or 3 (in the second step) despite optimal symptomatic treatment.
•8.Body weight >30kg
•9.No prior systemic anticancer therapy (chemotherapy, immunotherapy including durvalumab, or EGFR or ALK inhibitors) given as primary therapy for advanced or metastatic disease. Neoadjuvant or adjuvant chemotherapy is not considered as chemotherapy for advanced or metastatic disease.
•10.Limited field of radiation for palliation within 2 weeks of the first dose of durvalumab is allowed, provided the lung is not in the radiation field and irradiated lesion(s) cannot be used as target lesions.
•11.Age 18-70 years.
•12.Measurable tumor disease by CT per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
•13.Life expectancy > 8 weeks according to the investigator opinion.
•14.Adequate biological functions:
•neutrophils = 1500/mm3 ; platelets = 75 000/mm3 ; Hemoglobin = 9 g/dL ;
•Creatinine Clearance > 40 mL/min , AST and ALT = 2,5 ULN unless liver metastases are present, AST and ALT = 5 x ULN, serum bilirubine = 1.5 x ULN except for patients with proved, Gilbert syndrome (= 5 x ULN) or patients with hepatic metastases (= 3 x ULN).
•15.Other investigations detailed in Section 5 must have been performed within the timelines indicated.
•16.Protocol treatment is to begin within 7 days of patient inclusion.
•17.Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
•-Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
•-Women =50 years of age would be considered post-menopausal if they have been aamenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bila

排除标准

•1.Pure or combined SCLC.
•2.Known HER2, B-Raf, activating tumor mutations, or exon 14 c-MET splice mutations, or known ROS1 gene rearrangement.
•3.Asymptomatic or symptomatic brain metastasis.
•4.Carcinomatous meningitis.
•5.Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). 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
•-Patients without active disease in the last 5 years may be included but only after consultation with IFCT
•-Patients with celiac disease controlled by diet alone
•6.Immunosuppressive treatment including systemic treatment with corticosteroids with greater dose than 10 mg prednisone equivalent daily, within 15 days before enrollment. Inhaled, nasal or topic corticosteroids are allowed.
•7.History of allogenic organ transplantation.
•8.Stage 4 (very severe, FEV1<30% predicted) chronic obstructive pulmonary disease (COPD) according to GOLD classification.
•9.NYHA (New York Heart Association) class 4 chronic heart failure
•10.Pre-existing interstitial lung.
•11.History of another primary malignancy except for :
•Malignancy treated with curative intent and with no known active disease =2 years before the first dose of IP 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 residual disease
•Patients with a prostate adenocarcinoma history within the previous 5 years could be included in case of localized prostate cancer.
•12.Living attenuated vaccine received within the 30 previous days.
•13.Received any other experimental treatment or participation to any other therapeutic clinical trial.
•14.Known allergy or hypersensitivity to any of the study drug or any of the study drug excipients.
•15.Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
•16.Major surgical procedure within 28 days prior to the first dose of IP or planned surgical procedure during treatment.
•17.Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, 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.
•18.Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen (HBsAg) result) and hepatitis C,. 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. History of a

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发起方

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