A study to evaluate the relation between the efficacy and early Immune Related Advers Events of Nivolmab in patients with non-small cell lung cancer

A study to evaluate the relation between the efficacy and early Immune Related Advers Events of Nivolmab in patients with non-small cell lung cancer - A study to evaluate the relation between the efficacy and early Immune Related Advers Events of Nivolmab in patients with non-small cell lung cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000021560

Enrollment

100

Registered

2016-03-24

Start date

2016-03-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Age of 20 years old and older than 20 years old. 2)Histologically and/or cytologically proven non-small cell lung cancer. 3)Clinical stage IIIB without indication of definitive thoracic radiotherapy, stage IV, or postoperative recurrent disease. 4)ECOG performance status 0-2. 5)Adequate organ function.

Exclusion criteria

Exclusion criteria: 1)Subjects with autoimmune disease. 2)Subjects with interstitial lung disease. 3)Receiving continuous systemic corticosteroid. 4)Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. 5)Dementia or psychological disorder difficult to participate in this clinical study. 6)Uncontrolled intercurrent illness including symptomatic cardiac arrhythmia, or diabetes, Intestinal obstruction.

Design outcomes

Primary

Measure	Time frame
objective response rate,progression free survival	—

Secondary

Measure	Time frame
disease control rate overall survival	—

Countries

Japan

Contacts

Public ContactShunsuke Teraoka

Kobe city medical center general hospital Respiratory medicine

s.teraoka1105@gmail.com078-302-4321

Outcome results