An Observational Study to Predict the Efficacy and Optimal Duration of Treatment with Nivolumab in Patients with Previously Treated Advanced or Recurrent Non-Small Cell Lung Cancer

An Observational Study to Predict the Efficacy and Optimal Duration of Treatment with Nivolumab in Patients with Previously Treated Advanced or Recurrent Non-Small Cell Lung Cancer - New Epoch Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000023131

Enrollment

300

Registered

2016-07-12

Start date

2016-07-01

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)Patients with cytologically or histologically confirmed NSCLC 2)Patients who are not indicated for radical therapy, previously received at least one regimen of chemotherapy, and are planned to receive nivolumab as the second or third-line treatment in clinical practice 3)Patients aged 20 years or older who provided informed consent for this study 4)Patients with evaluable lesions according to the RECIST ver1.1

Exclusion criteria

Exclusion criteria: 1)Patients with EGFR mutations (Exon 19 deletion, L858R, T790M or other) and ALK fusion genes 2)Patients who are incapable of completing the EQ-5D-5L questionnaire 3)Patients who are on corticosteroid equivalent to/above 5 mg of prednisolone

Design outcomes

Primary

Measure	Time frame
Disease control rate at Month 6	—

Secondary

Measure	Time frame
1)Response rate (RR) 2)Correlation with each predictor for 2-year survival 3)Overall survival (OS), 1- and 2-year survival rates 4)Progression free survival (PFS) according to the RECIST 5)Clinical progression-free survival (cPFS) 6)Incidence of AEs such as skin disorder, diarrhoea, thyroid function and pulmonary toxicity 7)QOL score (EQ-5D-5L) at each evaluation time point	—

Countries

Japan

Contacts

Public ContactAkira Yamao

Public Health Reseach Foundation Comprehensive Support Project for Oncology Research

cspor-lc04@csp.or.jp03-5287-2636

Outcome results