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Clinical outcomes of the HIV protease inhibitor nelfinavir with concurrent chemoradiotherapy for unresectable stage IIIA/IIIB non–small cell lung cancer a phase 1/2 trial

JAMA Oncology Aug 28, 2019

Rengan R, Mick R, Pryma DA, et al. - In this prospective, open-label, single-group, single-institution phase 1/2 trial, researchers assessed the dose-limiting toxic effects, maximally tolerated dose, and recommended phase 2 dose of the protease inhibitor nelfinavir mesylate, administered concurrently with chemoradiotherapy in patients with locally advanced non–small cell lung cancer. In the phase 2 portion of the study, they investigated the objective response rate, local and distant failure rates, and overall survival. Enrollment of 35 patients with biopsy-confirmed unresectable stage IIIA/IIIB locally advanced non–small cell lung cancer (16 women and 19 men; median age, 60 years [range, 39-79 years]) was done for those who met protocol-specified criteria for adherence, with five at a dose of 625 mg twice daily and 30 at a dose of 1,250 mg twice daily. The patients showed good tolerability to nelfinavir with concurrent chemoradiotherapy. The treatment resulted in promising long-term local control and survival in these patients. Findings thereby suggest that in patients with locally advanced non–small cell lung cancer, the addition of the putative radiosensitizer nelfinavir with concurrent chemoradiotherapy may result in improved clinical effectiveness and outcomes.

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