Spots Global Cancer Trial Database for PhIb Study Evaluating Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC

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Trial Identification

Brief Title: PhIb Study Evaluating Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC

Official Title: 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

Study ID: NCT04141644

Conditions

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

Interventions

Ipilimumab

Osimertinib

Study Description

Brief 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.