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临床试验/JPRN-jRCT2031210107
JPRN-jRCT2031210107进行中（未招募）3 期

IMITED STAGE SMALL CELL LUNG CANCER (LS-SCLC): A PHASE III RANDOMIZED STUDY OF CHEMORADIATION VERSUS CHEMORADIATION PLUS ATEZOLIZUMAB - NRG-LU005

Kagamu Hiroshi0 个研究点目标入组 45 人开始时间: 2021年5月24日最近更新:
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适应症

试验速览

阶段
3 期
状态
进行中（未招募）
发起方
入组人数
45
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

入排标准

年龄范围
>= 18age old 至 ot applicable（—）
性别
All

入选标准

  • •Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer [AJCC] staging, 8th edition [Ed.]), within 60 days prior to registration
  • •Patients must have received one cycle of platinum/etoposide chemotherapy pre-registration (prior to study entry). Study registration must be within 21 days from day 1 of the pre-registration cycle of chemotherapy.
  • •Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) prior to the required cycle of platinum/etoposide chemotherapy
  • •Minimal staging requirements include:
  • •History/physical examination within 30 days prior to registration
  • •Positron emission tomography (PET)/computed tomography (CT) scan for staging within 60 days prior to registration
  • •CT chest and CT abdomen with IV contrast (unless contraindicated based on kidney
  • •function*) within 60 days prior to registration; MRI abdomen with IV contrast
  • •allowed in place of CT abdomen.
  • •Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast. The only exception to this is a documented life-threatening allergy
  • •Magnetic resonance imaging (MRI) scan of the brain with contrast (preferred) or CT scan of the brain with contrast (allowable if there is a contraindication with MRI with contrast) within 30 days prior to registration
  • •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration
  • •ANC >=1,500/cells/mm3
  • •Platelet Count >=100,000 cells/mm3
  • •Hemoglobin >=9 g/dL
  • •Total Bilirubin <=1.5 x ULN
  • •AST (SGOT) and ALT (SGPT) <=2.0 x ULN
  • •Adequate renal function within 30 days prior to registration defined as follows:
  • •Creatinine clearance >= 30 mL/min by the Cockcroft-Gault (C-G) equation:
  • •Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging
  • •Negative serum pregnancy test within 14 days of registration for pre-menopausal women of childbearing potential
  • •The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • •Hepatitis B/C testing prior to enrollment for patients that have not been tested before. Note: This is required even if the patient has never shown or had symptoms of hepatitis
  • •Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

排除标准

  • •Definitive clinical or radiologic evidence of metastatic disease
  • •Definitive surgical resection of small cell lung cancer
  • •Prior invasive malignancy (except non-melanomatous skin cancer, localized prostate cancer, or any early stage cancer treated with curative intent resection) unless disease free for a minimum of 2 years (carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • •More than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment; note that prior chemotherapy for a different cancer is allowable
  • •Any prior atezolizumab or other immunotherapy agent
  • •Prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields; prior tangent fields for breast cancer with minimal overlap with target volumes are allowed per approval of study principal investigators (PIs)
  • •Patients with cytologically positive pleural or pericardial fluid are not eligible
  • •An active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • •Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
  • •History of allogeneic organ transplant
  • •History of primary immunodeficiency
  • •Severe, active co-morbidity defined as follows:
  • •Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
  • •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • •Active tuberculosis
  • •Active hepatitis B (chronic or acute) or hepatitis C infection. Note that if hepatitis status is unknown, hepatitis B/C testing is required
  • •Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg]) test, a positive anti-HBc (antibody to hepatitis B core antigen), and a negative viral deoxyribonucleic acid (DNA) test (only obtained if HBsAg is found positive) are eligible
  • •Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test.)
  • •Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL)
  • •Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary
  • •Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months
  • •Transmural myocardial infarction within the last 3 months
  • •Clinically significant interstitial lung disease
  • •A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily

研究者

发起方
Kagamu Hiroshi

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