A study to evaluate the safety of Nivolumab in elderly patients with previously treated non-small cell lung cancer

Phase 2

• Conditions: non-small cell lung cancer

• Registration Number: JPRN-UMIN000020976
• Lead Sponsor: Hiroshima University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1)Subjects with interstitial lung disease which is detected by chest X-ray 3)Subjects with previous malignancies are excluded unless a complete remission was achieved at least 5 years prior to study entry. 4)Uncontrolled intercurrent illness including symptomatic cardiac arrhythmia, or diabetes, Intestinal obstruction. 5)known or suspected autoimmune disease, or receiving continuous systemic corticosteroid or immunosuppressant treatment. 6)Subjects with symptomatic CNS metastases or symptomatic carcinomatous meningitis. Subjects with asymptomatic CNS metastases, and subjects after 4 weeks from whole brain radiation therapy or 2 weeks from stereotactic brain radiation therapy can be included. 7)Radiation therapy within 4 weeks of the first dose of Nivolumab. 8)Subjects with known infection with HIV or AIDS . Positive test for hepatitis B virus antigen or hepatitis C virus indicating acute or chronic infection. 9)Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 10)Dementia or psychological disorder difficult to participate in this clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified