NCT04141644

Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC

A Phase Ib Study to Evaluate the Safety and Efficacy of Osimertinib in Combination With Ipilimumab in Patients With EGFR Mutated Non-Small-Cell Lung Cancer Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open label, interventional trial beginning with a phase 1b safety run-in followed by an expansion cohort.

Detailed description

The primary objective is to assess the short and long term tolerability of ipilimumab in combination with osimertinib. The secondary objective is to assess efficacy of osimertinib in combination with ipilimumab. Ipilimumab will be given for a total of four doses and osimertinib will be given until treatment discontinuation criteria is met. Ipilimumab at the assigned dose level every 3 weeks for four doses in combination with once daily osimertinib.

Conditions

• Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor (Disorder)

Interventions

Type	Name	Description
DRUG	Ipilimumab	Cohort 1: Osi 40 mg or 80 mg daily; Ipi 3 mg/kg every 3 weeks Cohort 2: Osi 40 mg or 80 mg daily; Ipi 1 mg/kg every 3 weeks
DRUG	Osimertinib	Cohort 1: Osi 40 mg or 80 mg daily; Ipi 3 mg/kg every 3 weeks Cohort 2: Osi 40 mg or 80 mg daily; Ipi 1 mg/kg every 3 weeks

Timeline

• Start date: 2020-08-20
• Primary completion: 2024-01-29
• Completion: 2028-04-30
• First posted: 2019-10-28
• Last updated: 2025-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study