Afatinib With Pembrolizumab for Treatment of Patients With Locally Advanced/Metastatic Squamous Cell Carcinoma of the Lung: The LUX-Lung IO/KEYNOTE 497 Study Protocol

Clinical Lung Cancer
Benjamin LevyJonathan W Riess

Abstract

Afatinib is a selective, irreversible ErbB family blocker that has shown survival benefit in lung squamous-cell carcinoma (SCC) patients. Pembrolizumab, a humanized immunoglobulin G4 monoclonal antibody to the programmed cell death 1 (PD-1) receptor, has also shown survival benefit in lung SCC. Concurrent inhibition of the PD-1 and epidermal growth factor receptor (EGFR) pathways represents a rational approach to improve responses and delay the onset of treatment resistance in lung SCC. This phase II, open-label, single-arm study (NCT03157089) is designed to assess the efficacy and safety of afatinib in combination with pembrolizumab in patients with stage IIIB/IV lung SCC that has progressed during/after first-line platinum-based chemotherapy. Eligible patients must have ≥1 target lesion (as per Response Evaluation Criteria in Solid Tumors version 1.1) and must have not received previous immune checkpoint inhibitor/EGFR-targeted therapy. The recommended phase II dose (RP2D) and safety profile will be determined during a safety run-in with oral afatinib (starting dose, 40 mg/d) with intravenous pembrolizumab (200 mg every 3 weeks). In the main study, all patients will receive afatinib at the RP2D with pembrolizumab until diseas...Continue Reading

Citations

Jun 13, 2020·Expert Review of Anticancer Therapy·Giulia SartoriSara Pilotto
Sep 12, 2020·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Soehartati A GondhowiardjoAngela Giselvania
Jun 27, 2020·Current Treatment Options in Oncology·Justin A Chen, Jonathan W Riess
Oct 17, 2020·OncoTargets and Therapy·Edgardo S Santos, Lowell Hart
Apr 4, 2021·International Journal of Molecular Sciences·Ryuhjin Ahn, Josie Ursini-Siegel

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