Pembrolizumab plus chemotherapy is currently used in the first-line treatment of advanced non-small-cell lung cancer without mutations or rearrangements, regardless of PD-L1 expression status. A study comparing chemotherapy plus pembrolizumab versus pembrolizumab alone has never been performed in patients with PD-L1 ≥50%. The aim of this trial is to perform such a comparison as first-line treatment in patients not eligible for locally advanced treatment who have expression of PD-L1 on ≥50% of tumor cells. The expected results are a reduction in the risk of early progression. A higher objective tumor response is also expected with the combination of chemotherapy and pembrolizumab compared with pembrolizumab alone. The study will allow a direct comparison of the proportion of patients who derive long-term benefit from the treatment. EudraCT (2020-002626-86); ClinicalTrials.gov (NCT04547504).
First-line pembrolizumab with or without platinum doublet chemotherapy in non-small-cell lung cancer patients with PD-L1 expression ≥50.
Future Oncol. 2021;17(23):3007-3016.
MeSH terms: Adult; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; B7-H1 Antigen; Carcinoma, Non-Small-Cell Lung; Clinical Trials, Phase III as Topic; Disease Progression; Female; Follow-Up Studies; Humans; Lung; Lung Neoplasms; Male; Middle Aged; Multicenter Studies as Topic; Progression-Free Survival; Prospective Studies; Randomized Controlled Trials as Topic; Response Evaluation Criteria in Solid Tumors
DOI: 10.2217/fon-2020-1202