Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC
NCT04141644 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-05-19
Summary
This is a prospective, open label, interventional trial beginning with a phase 1b safety run-in followed by an expansion cohort.
Conditions
- Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor (Disorder)
Interventions
- DRUG
-
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
-
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
Sponsors & Collaborators
- collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Matthew Gumbleton, MD · Huntsman Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-20
- Primary Completion
- 2024-01-29
- Completion
- 2028-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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