non-small cell lung cancer
Conditions
Interventions
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 time
Sponsors
Kaira Kyoichi
Nonprofit Organization, North East Japan Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =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 =95% 8.Serum creatinine =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 =95% 8.Serum creatinine <1.5 mg/dL (4) ECOG PS 0-2
Exclusion criteria
Exclusion criteria: Exclusion criteria for the first registration (1) Patients with synchronous multiple cancer or metachronous multiple cancer with = 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate at 12 months from secondary registration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) 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) | — |
Contacts
Public ContactAtsuto Mouri
Saitama Medical University International Medical Center
Outcome results
None listed