A Phase I/II Study of Necitumumab Plus Pembrolizumab, Nab-Paclitaxel, and Carboplatin for Previously Untreated Advanced Squamous Non-Small Cell Lung Cancer Study: (NEJ048A/NEXUS)

Background: Platinum-based combination therapy plus a programmed cell death 1/programmed cell death ligand 1 (PD-1/PD-L1) inhibitor is a standard treatment for patients with stage IV non-small cell lung cancer. However, necitu-mumab is used with gemcitabine and cisplatin as a first-line treatment option for squamous cell lung cancer (SqCLC). Furthermore, the combination of necitumumab with immune checkpoint inhibitors has the potential to enhance tumor immunity and improve the therapeutic effect. Thus, we planned and initiated this phase I/II study to evaluate the safety and efficacy of necitumumab plus pembrolizumab, nanoparticle albumin-bound (nab)-paclitaxel), and carbo-platin therapy for patients with previously untreated SqCLC. Patients and Methods: In phase I, the primary endpoint is the tolerability and recommended dose of necitumumab combined with pembrolizumab plus nab-paclitaxel and carbo-platin. In phase II, the primary endpoint is the overall response rate. Secondary endpoints are disease control rate, progression-free survival, overall survival, and safety. For ty-t wo patients will be enrolled in phase II. Conclusion: This is the first study to investigate the efficacy and safety of necitumumab plus pembrolizumab combined with platinum-based chemotherapy in patients with previously untreated SqCLC.Clinical Lung Cancer, Vol. 24, No. 4, 371-375 (c) 2023 The Author(s). Published by Elsevier Inc.This is an open access article under the CC BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/4.0/ )

Automated summary

This study aims to evaluate the safety and efficacy of necitumumab plus pembrolizumab, nanoparticle albumin-bound paclitaxel, and carboplatin therapy in previously untreated squamous cell lung cancer (SqCLC) patients. Phase I evaluates the tolerability and recommended dose of the combination therapy, while phase II assesses the overall response rate and secondary endpoints including disease control rate, progression-free survival, overall survival, and safety. It is the first study to investigate the efficacy and safety of necitumumab plus pembrolizumab combined with platinum-based chemotherapy in previously untreated SqCLC patients.