Primo N. Lara Jr, MD
Clinical trial designs are undergoing a dramatic transformation geared toward the discovery and validation of new predictive biomarkers for patients with non–small cell lung cancer (NSCLC) and other types of solid tumors, according to a presentation by Primo N. Lara Jr, MD, at the 2015 International Lung Cancer Congress.
Once next-generation sequencing and other molecular profiling is conducted, clinical trials that randomize patients based on their genetics become more plausible. To this end, in the past 5 years, basket and umbrella protocols have been formed and the NCI has enhanced the study of exceptional responders. These steps are essential to accelerating biomarker development, Lara added.
In an umbrella trial, upfront next-generation sequencing is conducted and patients are randomized based on the results to smaller individualized arms or substudies. Each smaller group explores a targeted therapy matched to the patient’s biology. This type of trial generally explores various markers within a single histology and can grow to be very large, with 20 or more arms.
, and other markers. Immunotherapy will be administered for those without an apparent molecular driver and chemotherapy will be used as a comparator (NCT02154490).
In a basket trial, patients with various types of cancer are enrolled based on the presence of a biomarker, such as a genetic alteration or a distinct molecular signature. This style of trial takes the emphasis off histology and focuses it on the underlying genetics of each tumor. Typically, these protocols explore a single therapy across various types of cancer.
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