Lung cancer continues to be one of the biggest public health challenges facing the United States and many other countries. Although incidence rates have stabilized, more than 173,000 new cases of lung cancer will be diagnosed this year, and it will continue to be the most common cause of cancer death among men and women, with more than 163,000 people succumbing to the disease each year.

NCI recognizes the public health imperative of ensuring that we are doing the most with available resources to tackle this formidable challenge. This recognition led to the formation in 2004 of the Lung Cancer Integration and Implementation (I2) Team ¹, one of a handful of special groups including NCI staff and extramural researchers focused on high-priority areas of research. In a Director's Update ² last summer, Dr. Andrew von Eschenbach praised the Lung Cancer I2 team for their work in identifying gaps and opportunities to accelerate our efforts against lung cancer. I am continuing to lead this effort by creating a base of scientific cohesiveness within the Institute around lung cancer, and will host regular meetings with extramural lung cancer researchers and advocates about our progress in this area and our future agenda. The original I2 team will continue to participate in this effort via monthly conference calls.

We are now launching the NCI Lung Cancer Program (LCP). Using funds from the NCI Director's discretionary budget reserve, the central focus of this program will be to support research into early detection and treatment, efforts we believe are most likely to provide more immediate benefits for lung cancer patients.

An important aspect of the LCP will be initiation of two clinical trials. The first will be a national clinical trial with the primary goal of defining a panel of genomic and proteomic pharmacodynamic markers that can be used to predict response to EGFR inhibitors, such as erlotinib (Tarceva), in patients with non-small-cell lung cancer (NSCLC). The trial will be designed to screen about 1,000 NSCLC patients - enough to identify those with molecular signatures that correlate with erlotinib effectiveness. We hope that this trial will provide a generalized approach for patient selection that could be used as a basis to direct similar investigations.

The second study will begin as an early-phase trial at the NIH Clinical Center to test a DNA methylase inhibitor that has shown the ability to, in effect, reactivate tumor suppressor genes. As a study published earlier this year ³ demonstrated, these genes can be "silenced" when overmethylated, leading to aggressive cellular behavior. This pilot trial offers an opportunity to bring forward a potentially important lung cancer therapeutic agent.

Other parts of the LCP program will include an RFA from the Division of Cancer Biology that will be directed at the biology of very early changes in the lung, inflammation, and the tumor microenvironment. Also, additional resources have been committed to the Cancer Intervention and Surveillance Modeling Network to improve our understanding of the impact of cancer control interventions - specifically in tobacco cessation, early detection and screening, and therapy. Finally, additional funds have been committed to support tissue acquisition, processing, and archiving in the National Lung Screening Trial ⁴.

While the LCP will not initially increase support to tobacco control programs, NCI will continue to work toward finding resources for those initiatives identified by the I2 Team. Be assured, however, that existing NCI tobacco control research remains a priority, for we cannot forget that the great majority of lung cancers can be prevented through prevention and cessation of smoking and other forms of tobacco use.

Dr. John E. Niederhuber
NCI Deputy Director and Deputy Director for Translational and Clinical Sciences