JPRN-jRCTs031190070已完成2 期
A Phase II Study of daily carboplatin plus irradiation followed by Durvalumab for previously-untreated Stage III NSCLC patients with PS 2 and/or high age - NEJ039A
Kaira Kyoichi0 个研究点目标入组 95 人开始时间: 2019年8月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Inclusion criteria for the first registration
- •(1) Patients must have histologically- or cytologically-documented NSCLC who present with unresectable disease (c-Stage IIIA, IIIB or IIIC), amenable to curative radiotherapy
- •(2) Previously untreated patients
- •(3) Patients aged <=74 years with ECOG PS 2 or those aged >=75 years with PS 0-1, not amenable to platinum-based chemotherapy concurrent with radiotherapy
- •(4) Patients aged >=20 years at informed consent
- •(5) Patients with measurable lesion that can be evaluated by RECIST (version 1.1)
- •(6) Patients who meet the following criteria for major organ functions within 14 days prior to the registration
- •If more than one test result is available, the value from the test performed on the closest time to the registration date should be adopted. Blood transfusion and administration of hematopoietic factor preparations are prohibited within 14 days prior to the test day
- •1.Neutropenia count >=1,500/mm3
- •2.Haemoglobin >=9.0 g/dL
- •3.Platelet count >=10.0 x 10,000/mm3
- •4.AST <=2.5 times the upper limit of normal (ULN)
- •5.ALT <=2.5 times the upper limit of normal (ULN)
- •6.Total bilirubin <=1.5 times the upper limit of normal (ULN) (or <=3 times ULN in the presence of unconjugated hyperbilirubinaemia such as Gilbert's syndrome)
- •7.SpO2 >=95%
- •8.Serum creatinine <1.5 mg/dL
- •(7) Life expectancy >=12 weeks
- •(8) Patients who provided the written informed consent after having sufficient explanation on this study
- •Inclusion criteria for the second registration
- •(1) Patients who have received a total thoracic radiotherapy >= 40 Gy and at least 10 doses of daily carboplatin
- •(2) Tumor response after daily carboplatin + concurrent thoracic radiotherapy was confirmed to be non-PD based on RECIST
- •(3) Patients who meet the following criteria for major organ functions within 14 days prior to the registration. If more than one test result is available, the value from the test performed on the closest time to the registration date should be adopted.
- •1.Neutropenia count >=1,500/mm3
- •2.Haemoglobin >=9.0 g/dL
- •3.Platelet count >=10.0 x 10,000/mm3
- •4.AST <=2.5 times the upper limit of normal (ULN)
- •5.ALT <=2.5 times the upper limit of normal (ULN)
- •6.Total bilirubin <=1.5 times the upper limit of normal (ULN) (or <=3 times ULN in the presence of unconjugated hyperbilirubinaemia such as Gilbert's syndrome)
- •7.SpO2 >=95%
- •8.Serum creatinine <1.5 mg/dL
- •(4) ECOG PS 0-2
排除标准
- •Exclusion criteria for the first registration
- •(1) Patients with synchronous multiple cancer or metachronous multiple cancer with <=5 years of disease-free interval
- •However, carcinoma in situ and intramucosal carcinoma that are judged to be cured by local therapy are not excluded.
- •(2) Patients with interstitial pneumonia, drug-induced Interstitial lung disease or clinically active interstitial lung disease confirmed by chest CT
- •(3) Contralateral hilar lymph node, single-lung atelectasis, malignant pleural effusion or malignant pericardial effusion
- •(4) Any evidence of active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
- •If the patient has HBs antigen positive, HBs antibody positive, or HBc antibody positive, HBV DNA should be tested. Patients with HBV DNA positive will be excluded.
- •(5) Mixed small cell and non-small cell lung cancer histology
- •(6) Patients with primary immunodeficiency
- •(7) Patients with disease that has an impact on digestive function, such as total gastrectomy or active inflammatory bowel disease, or patients with dyspepsia syndrome.
- •(8) Patients with contraindications for carboplatin treatment
- •(9) Active or prior documented inflammatory bowel disease (eg, Crohn's Disease, ulcerative colitis)
- •(10) Patients with severe complications such as uncontrolled heart, lung, liver, or kidney disease
- •(11) Patients who are treated with systemic corticosteroids for >= 4 weeks.
- •However, systemic corticosteroids not to exceed 10 mg/day of prednisone or its equivalent are acceptable
- •(12) Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
- •Patients who have received local therapy (local excision or local radiation) for isolated lesions except for target lesions as palliative treatment are eligible.
- •(13) Active or prior documented autoimmune disease within the past 2 years
- •Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- •(14) Any of the following cardiac criteria:
- •Resting corrected QT interval (QTc) > 470 msec calculated
- •Please repeat ECG study when the outlier of ECG findings is detected.
- •Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block and second degree heart block, PR interval > 250 msec etc.)
- •Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.
- •(15) Male patients without an intention to use the measures of contraception. Or pregnant women, lactating women, women who are positive for pregnancy tests or women without an intention to use the measures of contraception.
- •However, the following female patients can be enrolled;
- •Female patients aged >=50 years who have been amenorrheic for 12 months or more
- •Female patients aged <50 years who would be considered postmenopausal if they have been amenorrheic for 12 months or more and if they have luteinizing hormone and folliclestimulating hormone levels in the postmenopausal range
- •Female patients who underwent surgical sterilization (hyst
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