drugset / Trial / NCT03091491
Study of Nivolumab Verses Nivolumab and Ipilimumab Combination in EGFR Mutant Non-small Cell Lung Cancer
Phase 2
Terminated
31 enrolled
National Cancer Centre, Singapore
Johns Hopkins Singapore · collabNational University Hospital, Singapore · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-04-07
- Primary completion
- 2019-11-18
- Completion
- 2019-11-18
Outcome
Outcome not reported
Stopped (Enrollment): “Slow recruitment due to general pessimism for immunotherapy in NSCLC, availability of alternative therapy and clinician's choice to put patient on immunotherapy outside of trial setting.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |