NCT03091491

Study of Nivolumab Verses Nivolumab and Ipilimumab Combination in EGFR Mutant Non-small Cell Lung Cancer

Randomised Phase 2 Study of Nivolumab Versus Nivolumab and Ipilimumab Combination in EGFR Mutant Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study examines the outcome of nivolumab single agent versus nivolumab-ipilimumab combination in patients with advanced EGFR+ NSCLC who have failed one line of standard EGFR Tyrosine Kinase Inhibitor (TKI) and not more than one line of chemotherapy regimen. 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. Patients will be randomized in a 1:1 ratio to treatment with either nivolumab monotherapy (Arm A) or nivolumab/ipilimumab combination therapy (Arm B) and will be stratified according to the following factors: * Programmed Death-Ligand 1 (PDL1) status: \<1% vs ≥1% * Presence of brain metastasis * Institution: National Cancer Centre Singapore, National University Cancer Institute, and Johns Hopkins Singapore-Tan Tock Seng Hospital Both arms will continue with treatment regimen till disease progression or discontinuation of treatment due to adverse events. Arm A patients are allowed to cross over to Arm B in the event of clear-cut disease progression. On-study tumor assessments will be conducted every 6 weeks for 24 weeks and then every 12 weeks till clear-cut disease progression. The radiologist will be blinded to the treatment arm that the patient is randomised to ensure an objective response evaluation.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Ipilimumab	Ipilimumab 1 mg/kg administered every 6 weeks as a 30 min IV infusion
DRUG	Nivolumab	Nivolumab 3 mg/kg administered every 2 weeks as a 30 min IV infusion

Timeline

• Start date: 2017-04-07
• Primary completion: 2019-11-18
• Completion: 2019-11-18
• First posted: 2017-03-27
• Last updated: 2022-06-14

Locations

3 sites across 1 country: Singapore