DATE study
- Conditions
- ntreated locally advanced stage III NSCLC
- Registration Number
- JPRN-jRCTs031190117
- Lead Sponsor
- KUBOTA Kaoru
- Brief Summary
This study met its primary endpoint. Durvalumab maintenance therapy can be safely administered immediately after completion of concurrent chemoradiation therapy in patients with unresectable stage III NSCLC, no additional or unexpected toxicity occurred as a reference to the PACIFIC study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
1) Histologically or cytologically confirmed NSCLC (mixed small cell and no-small cell lung cancer histology is not allowed).
2) Untreated (open biopsy is allowed), locally advanced, Stage III (IIIA, IIIB, IIIC) disease according to Version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology.
3) Patients with measurable lesions based on RECIST v1.1.
4) Patients without indications for surgical resection.
5) No history of chemotherapy (including molecular targeting medicines, immune checkpoint inhibitors) chest radiotherapy, or any other treatment for other carcinomas (Oral anti-cancer drug treatment as adjuvant chemotherapy for other cancer types surgery, endoscopic mucosal resection (ESD,EMR) hormone therapy and radiation therapy for areas other than brain and chest in the past are acceptable).
6) Radical concurrent chemoradiotherapy is possible. v20Gy(the volume of lung parenchyma that received 20Gy or more) was less than 35% according to three-dimensional treatment plan.
7) Aged 20 years or older, under 75 years.
8) Patients who exceed 30kg in weight.
9) ECOG Performance Status (PS) 0-1.
10) Adequate organ and marrow functions.
Absolute neutrophil count >1500/mm3
Hemoglobin >=9.0 g/dL.
Platelets >100000/mm3.
AST and ALT <= 100 IU/L.
Serum bilirubin <= 1.5 mg/dL.
Serum creatinine <= 1.5 mg/dL.
SpO2>=92% or PaO2>=70torr(room air).
11) Life expectancy >=12 weeks.
12) Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered postmenopausal if they are amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply.
Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution.
Women >=50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, radiation-induced oophorectomy with last menses >1 year ago, chemotherapy-induced menopause with >1year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy).
13) Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
14) Provision of signed, written and dated informed consent prior to any study specific procedures.
1 ) Patients with superior vena cava syndrome who have difficulty in high-volume infusion
2 ) Patients with contralateral hilar lymph nodes, malignant pericardial effusion, malignant pleural effusion, and lymphangiosis carcinomatosa of the lungs
3 ) Patients with obvious interstitial pneumonia or pulmonary fibrosis on chest CT
4 ) History of another primary malignancy within 5 years
5 ) Recent major surgery with organ resection within 4 weeks (excluding surgery for cytology, biopsy, trial thoracotomy and local surgery for palliation )
6 ) Patients with a history of active primary immunodeficiency
7 ) Patients with allogeneic organ transplantation history
8 ) Patients who have or have had confirmed autoimmune or inflammatory disease
9 ) Patients who receive continuous systemic administration of steroids or other immunosuppressive drugs with the exceptions of with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. CT scan Pre-administration for hypersensitivity is allowed.
10 ) Patients with active infection such as tuberculosis, hepatitis B, human immunodeficiency virus ( HIV ) infection
11 ) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
12 ) Mean QT interval corrected for heart rate (QTc) >=470 ms calculated from 3 electrocardiograms (ECGs) using Fridericias Correction
13 ) Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving study drug
14 ) Patients with a history of severe allergies or hypersensitivity to therapeutic agents
15 ) Patients who are medically contraindicated for platinum doublet chemotherapy
16 ) Patients judged to be difficult to enroll in this study due to mental illness
17 ) Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control(Patients who have no intention of contraception during the treatment period and at least 90 days after the end of treatment ). Patients who are willing to donate blood during the treatment period and at least 90 days after the end of treatment.
18 ) Patients who are willing to donate blood during the treatment period and at least 90 days after the treatment
19 ) Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year PFS rate
- Secondary Outcome Measures
Name Time Method Safety, response rate, 1-year PFS rate ( from the start of durvalumab maintenance therapy ), PFS, 2-year PFS rate, 1-year / 2-year survival rate Both from the start of durbarumab maintenance therapy )