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Michael R. Shafique, MD, discusses the dose escalation and expansion of pepinemab in the phase 1b/2, single arm, first-in-human, CLASSICAL-Lung study in advanced non-small cell lung cancer.
Michael R. Shafique, MD, a medical oncologist in the Department of Thoracic Oncology at Moffitt Cancer Center, discusses the dose escalation and expansion of pepinemab in the phase 1b/2, single arm, first-in-human, CLASSICAL-Lung study in advanced non-small cell lung cancer (NSCLC).
The CLASSICAL-Lung study evaluated the safety, tolerability, and efficacy of pepinemab in combination with avelumab (Bavencio) in patients with NSCLC. The CLASSICAL-Lung study is comprised of 2 phases, says Shafique. The dose-escalation phase primarily enrolled patients who had not been previously treated with immunotherapy; these patients only received prior chemotherapy. The study also allowed for patients who had declined receiving chemotherapy to enroll, meaning this would be their first time receiving any immunotherapy.
The second phase was the dose-expansion portion of the trial, which consisted of 2 separate cohorts of patients. The first cohort included patients who had never received immunotherapies, while the second cohort included patients who had progressed on prior immunotherapy. The overall goal of the study was to identify the recommended phase 2 dose of the treatment, as well as to collect preliminary efficacy data on the combination of these 2 drugs, concludes Shafique.