Phase I trial of a treatment of nivolumab combined with stereotactic body radiotherapy for patients with multiple metastatic non-small cell lung cancer.
- Conditions
- non-small cell lung cancer with two or more lesions including at least lung or pluera
- Registration Number
- JPRN-UMIN000023645
- Lead Sponsor
- Department of Radiology, University of Yamanashi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
Not provided
1)Active double cancer(except for some early or cured cancer as followe:carcinoma in situ, mucosal cancer, stage I prostate, breast, or laryngeal cancer) 2)Serious heart disease,uncontrolled diabetes mellitus despite continuing treatment of insulin,cardiac infarction within 6 months before enrollment,uncontrolled hypertension,history of severe infections,watery diarrhea,paresis of intestine,ileus,autoimmune disease,other severe complications 3)Radiographically (chest X-P or CT image) confirmed interstitial pneumonitis or pulmonary fibrosis 4)Severe emphysema, chronic bronchitis, asthma 5)Continuous systemic administration of steroid 6)Severe mental illness 7)women who are or may be pregnant or in lactatoin 8)Unsuitable patients judged by the attending physician or radiation-oncologist(previous irradiation is ignored)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ratio of cases with grade four/five or aggravation of two or more toxicity grade within 24 weeks after the start of therapy.
- Secondary Outcome Measures
Name Time Method The reduction ratio in size of irradiated lesions and the non-irradiated lesion at 24 weeks after start of treatment. The change of the tumor marker level as of 24 weeks after start of treatment and stereotactic body radiotherapy. The expression ratio of PD-L1 in the tumor before the start of treatment. The ratio of case with one or two aggravation of toxicity grade within 24 weeks after the start of therapy.