NCI/FDA Lung Cancer Workshop Leads to the Innovatively Designed Clinical Trials

The gist: Clinical trials are research studies with volunteer patients. They are often used to test how safe and effective new cancer treatments are. Patients can enroll in them to gain access to new treatments. Recently, researchers launched two new clinical trials for lung cancer patients. (One of them, called ALCHEMIST, was recently covered by our Chief Scientist on our Need to Know blog.) Both trials aim to maximize benefit to patients and researchers alike through molecular testing and carefully matching patients with the treatments most likely to work for them. This is a relatively new approach to clinical trial design that may herald a widespread shift for the whole field of cancer research.

“The recent launch of two clinical trials offer innovative study designs for patients with lung cancer. These clinical trials are the direct result of a National Cancer Institute (NCI) sponsored workshop chaired by Drs. Fred R. Hirsch, Shakun Malik and Claudio Dansky- Ullman, that brought together the NCI Thoracic Malignancies Steering Committee, the US Food and Drug Administration (FDA), academicians, clinicians as well as industry and government stakeholders to discuss issues and challenges related to clinical trial design and biomarkers for lung cancer targeted-therapies.

“The purpose of the NCI/FDA workshop was to collaboratively design a high priority biomarker-driven clinical trial that could expeditiously evaluate the clinical utility of a targeted-therapy in a molecularly defined lung cancer population and aid in data collection needed for regulatory approval. The workshop, whose consensus report appears in the October issue of the Journal of Thoracic Oncology, the official journal of the International Association for the Study of Lung Cancer (IASLC), discussed the types of biomarkers (prognostic vs predictive), the various clinical trial designs that can be employed with predictive biomarkers as well as primary endpoints for clinical trials. Also discussed were the regulatory challenges related to drug development, biomarker and biomarker assay development, trial design, and the amount of data needed for approval of both drugs and in vitro diagnostics. The attendees agreed that ‘in order to accelerate development of biomarker-driven trials it is critical to enhance coordination between pharmaceutical industries, FDA, academic and community-based clinical investigators, NCI, and patient organizations with the intention to enhance collaboration between these organizations, bring forward new drugs much more rapidly for approval and ultimately improving long-term outcomes for patients.’ “

ALCHEMIST Aims to Curtail Return of Early-Stage Lung Cancer

A series of three new clinical trials (research studies with volunteer patients) is big news for some people affected by early-stage lung cancer. The trials focus on two drugs typically used to treat late-stage adenocarcinoma. These two drugs, Tarceva and Xalkori, may also help stage I, II, and IIIA patients prevent relapse (return of cancer) after their tumors have been surgically removed. The new clinical trials will put the treatments to the test. Continue reading…