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A phase II study evaluating immune-priming effect of Nivolumab in combination with palliative radiationtherapy in previously treated patients with non-small cell lung cancer.

Phase 2
Conditions
on small cell lung cancer
Registration Number
JPRN-UMIN000023646
Lead Sponsor
HANSHIN cancer study group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
28
Inclusion Criteria

Not provided

Exclusion Criteria

1.History of severe drug allergy 2.Side effects of previously treatment is existed and disturb safety analysis 3.urrent or previous History of auto immune disease 4.Pulmonary fibrosis detected by chest CT or clinical examination 5.current or previous history of diverticulitis or ulcerative disease of GI 6.History of active double cancer with in 5 years 7.History of pericardial effusion/ pleural effusion/ ascites with treatment needed. 8.Brain metastasis required for radiation therapy. 9.uncontrolled pain due to bone metastasis 10.Current or previous (within the last 180days) history of symptomatic cerebrovascular disease or thromboembolism. 11.Uncontrollable severe cardiovascular disease 12.Uncontrollable diabetes mellitus 13. previous (within the last 14 days) pleurodesis 14.previous (within the last 28 days) operation with systemic anesthesia 15.previous (within the last 56 days) thoracic radiation therapy with over 40Gy. 16.systemic infectious disease require treatment. 17.Active hepatitis type B or typeC 18.Sever side effect caused by previously treated immune checkpoint blockade. 19.History of active psychological disease. 20.History of dementia 21.Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Response rate(extra field of radiation therapy)
Secondary Outcome Measures
NameTimeMethod
Overall survival, Progression free survival , disease control rate, Toxicity,
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