drugset / Trial / NCT01998126

Combination Checkpoint Inhibitor Plus Erlotinib or Crizotinib for EGFR or ALK Mutated Stage IV Non-small Cell Lung Cancer

NCT01998126

Phase 1 Completed 14 enrolled University of Utah Bristol-Myers Squibb · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goals of the overall study are to evaluate a recommended phase 2 dose and the short and long term toxicities of the combinations. This is a modified phase I trial of immune checkpoint inhibitors in combination with mutation - specific targeted therapy (crizotinib or erlotinib) at conventional doses stratified for presence of ALK (Anaplastic lymphoma kinase) or EGFR (epidermal growth factor receptor) mutation. The goals of the overall study are to evaluate a recommended phase 2 dose and the short and long term toxicities of the combinations.

Timeline

Start
2013-12-02
Primary completion
2017-05-09
Completion
2018-03-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Crizotinib Small molecule 250 mg
Subject Erlotinib Small molecule 150 mg
Subject Ipilimumab Monoclonal antibody 1 mg/kg
Subject Ipilimumab Monoclonal antibody 3 mg/kg
Subject Nivolumab Monoclonal antibody 240 mg