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
Not Applicable
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000023131
- Lead Sponsor
- PHRF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease control rate at Month 6
- Secondary Outcome Measures
Name Time Method 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