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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031190070

Registered date:07/08/2019

A Phase II Study of daily carboplatin plus irradiation followed by Durvalumab for previously-untreated Stage III NSCLC patients with PS2 and/or high age

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiednon-small cell lung cancer
Date of first enrollment07/08/2019
Target sample size95
Countries of recruitment
Study typeInterventional
Intervention(s)Radiotherapy 2 gray once a day, 5 days a week, total 30 times and 60 gray, 6week total treatment period Chemotherapy Carboplatin 30mg/m2 intravenous dosage once a day, 5 days a week, total 20 times, Administration of carboplatin is began the start date of radiotherapy concurrently. Durvalmab 10 mg/kg intravenous dosage once two weeks

Outcome(s)

Primary OutcomeProgression-free survival rate at 12 months from secondary registration
Secondary Outcome1) Time to treatment failure followed by first registration 2) Time to treatment failure followed by secondary registration 3) Completion rate of carboplatin and radiotherapy 4) Completion rate of durvalmab maintenance therapy (durvalmab) 5) Progression-free survival followed by first registration (carboplatin+radiotherapy) 6) Progression-free survival followed by second registration (durvalmab) 7) Survival rate at 2 years from first registration (carboplatin+radiotherapy) 8) Survival rate at 2 years from second registration (durvalmab) 9) Reduction rate of carboplatin and radiotherapy 10) Response rate of durvalmab maintenance therapy 11) Safety of carboplatin and radiotherapy (the rate of adverse events and the severity) 12) Safety of durvalmab maintenance therapy (the rate of adverse events and the severity) 13) Exploratory evaluation points (biomarker)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaInclusion 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
Exclude criteriaExclusion 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 (hysterectomy, bilateral oophorectomy or tubal interruption). (16) Known allergy or hypersensitivity to any of the study drugs (17) Participation in a durvalumab clinical study regardless of whether durvalumab has been given (18) History of allogenic organ transplantation (19) Other cases that are determined to be inappropriate by investigator Exclusion criteria for the second registration (1) Patients with >=grade 1 radiation pneumonitis (2) Any unresolved toxicity CTCAE >Grade 2 (except for radiation pneumonitis) from the prior chemoradiation therapy (3) Patients who do not meet the eligibility criteria within 42 days from the completion of radiation therapy (4) Uncontrolled intercurrent illness, active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, hemorrhagic diarrhea, psychiatric illness, psychosis or psychiatric symptoms, which in the investigator's opinion makes it undesirable for the patient to participate in the study (5) Receipt of live attenuated vaccination within 30 days prior to the second registration or within 30 days of receiving durvalumab (6) Recent major surgery within 4 weeks prior to the second registration (excluding theplacement of vascular access) that would prevent administration of durvalumab (7) Other cases that are determined to be inappropriate by investigator

Related Information

Contact

Public contact
Name Atsuto Mouri
Address 1397-1, Yamane, Hidaka-city, Saitama Saitama Japan 350-1298
Telephone +81-42-984-4111
E-mail mouriatsuto@gmail.com
Affiliation Saitama Medical University International Medical Center
Scientific contact
Name Kyoichi Kaira
Address 1397-1, Yamane, Hidaka-city, Saitama Saitama Japan 350-1298
Telephone +81-42-984-4111
E-mail kkaira1970@yahoo.co.jp
Affiliation Saitama Medical University International Medical Center