The purpose of this study is to determine whether Nivolumab in combination with Ipilimumab is associated with superior response rate compared to Nivolumab alone in patients with advanced Epidermal Growth Factor Receptor (EGFR) mutation positive Non-small Cell Lung Cancer who have failed one line of standard EGFR tyrosine kinase inhibitor and not more than one line of chemotherapy regimen. This study also aims to determine predictive biomarkers of response/benefit in patients with EGFR mutation positive NSCLC.
Name: Ipilimumab
Description: Ipilimumab 1 mg/kg administered every 6 weeks as a 30 min IV infusionType: DrugNivolumab and Ipilimumab
Name: Nivolumab
Description: Nivolumab 3 mg/kg administered every 2 weeks as a 30 min IV infusionType: DrugNivolumab Nivolumab and Ipilimumab
Description: Safety data of all adverse events and serious adverse events, will be graded according to the NCI CTCAE v 4.0.
Measure: Evaluate the toxicity profiles of Nivolumab with or without Ipilimumab by measuring the number of participants with treatment-related adverse events Time: From the time the Informed Consent Form is signed until at least 100 days after discontinuation of dosing, up to 2 yearsDescription: Biomarkers: PD-L1, mutational burden, microsatellite instability, blood-based biomarkers
Measure: Evaluate an array of biomarkers in predicting response to Nivolumab and/or Ipilimumab Time: From time of first dose of study treatment until clear-cut disease progression, up to 2 yearsAllocation: Randomized
Parallel Assignment
There is one SNP
Eastern Cooperative Oncology Group (ECOG) 0-2 performance status v. Progressed on one line of standard EGFR TKI and not more than one line of chemotherapy; 3rd generation EGFR TKI for patients with T790M mutation is allowed - A 14-day washout period is required for EGFR TKI for patients who received this as the last therapy before recruitment - A 28-day washout period is required for chemotherapy for patients who received this as the last therapy before recruitment. --- T790M ---
The use of 3rd generation EGFR TKI for patients with acquired mutation that substitute a threonine (T) with a methionine (M) at position 790 of exon 20 (T790M) is allowed. --- T790M ---