Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer

Summary

This phase II trial studies how well pembrolizumab works in treating patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer that have not received prior tyrosine kinase inhibitor therapy and has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may block growth in different ways by targeting certain cells.

Timeline

Start

2016-09-15

Primary completion

2017-11-30

Completion

2019-01-03

Outcome

Missed primary endpoint

paper Enrollment was ceased due to lack of efficacy after 11 of 25 planned patients were treated. PMID 29874546 ↗

paper suggests that it is not an appropriate therapeutic choice in this setting. PMID 29874546 ↗

Publications

• Lisberg A, Cummings A, Goldman JW, Bornazyan K, Reese N, Wang T, Coluzzi P, Ledezma B, Mendenhall M, Hunt J, Wolf B, Jones B, Madrigal J, Horton J, Spiegel M, Carroll J, Gukasyan J, Williams T, Sauer L, Wells C, Hardy A, Linares P, Lim C, Ma L, Adame C, Garon EB. A Phase II Study of Pembrolizumab in EGFR-Mutant, PD-L1+, Tyrosine Kinase Inhibitor Naive Patients With Advanced NSCLC. J Thorac Oncol. 2018 Aug;13(8):1138-1145. doi: 10.1016/j.jtho.2018.03.035. Epub 2018 Jun 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Indications