Current and Upcoming NSCLC Clinical Trials at Duke
A clinical trial is a research study with human volunteers. Today, clinical trials are central to translating medical research into proven patient care. Each study is designed to answer specific questions. Answering the questions leads to better ways to prevent, diagnose, or treat cancer. The goal of many clinical trials is to show whether investigational drugs or new medical procedures are effective in the treatment of a specific condition. The use of genomic profiles in making decisions about treatment approaches is very new and therefore we need to determine the best way to use them in this manner. Since this approach to treatment is still being developed, genomic profiles are currently available only to patients taking part in clinical trials. The goal of our NSCLC clinical trials is to collect more information about the genomics profiles of different types of NSCLC tumors. We currently have open NSCLC genomics trial, and more trials will open in the future.
Trial for Advanced Stage NSCLC
In May 2007, our clinical trial to study platinum-sensitivity opened to patients. The trial uses genomic profiles to identify which cancers are resistant and which are sensitive to platinum chemotherapy. Trial participants with platinum sensitive tumors are treated with platinum based chemotherapy, while trial participants with platinum resistant tumors are treated with a combination of pemetrexed and gemcitabine, drugs approved by the Federal Drug Administration (FDA) for use in the treatment of NSCLC. The trial will help us understand how effective genomic profiles are in guiding treatment choices. The Advanced Stage NSCLC trial is open to men and women with newly diagnosed stage IIIB or IV NSCLC.
We are also in the planning stages for a clinical trial to study the test the effectiveness of the drug dasatinib, which is an FDA approved drug for the treatment of other types of cancer, in patients who have already received other treatment for their advanced NSCLC. We hope this trial will open in 2008.
Trials for Early Stage NSCLC
Our clinical trial to study a genomic profile for vinorelbine and pemetrexed sensitivity in stage IB, II, or IIIA NSCLC opened at Duke in October 2007. The trial uses genomic profiles to study if we can pinpoint which NSCLC tumors are best treated with different chemotherapy combinations. We are studying the combinations of cisplatin with pemetrexed or cisplatin with vinorelbine. Both of these chemotherapy combinations are FDA approved for treating NSCLC. This trial is open to men and women who had had a recent surgical removal of their NSCLC. This trial will provide important information on the use of genomic profiles to guide chemotherapy choices.
Our clinical trial to study the effectiveness of the targeted drug dasatinib in early stage lung cancer opened at Duke in November 2007. The trial evaluates giving dasatinib during the period that comes before the start of standard treatment of surgery. This is called neoadjuvant treatment.
This trial will give us information about about how effective dasatinib is in reducing the size of NSCLC tumors. We will also get information that will be used to evaluate whether information derived from genomic profiles can predict which patients are most likely to benefit from dasatinib prior to surgery and after surgery. The trial will is open to men and women with newly diagnosed stage IB, IIA, or IIB NSCLC.
A trial to study the genomic tool Lung Metagene Score (LMS) is planned for start in 2008. Once the tool is fully developed, the LMS may allow doctors to estimate the risk of early stage NSCLC recurring. The LMS is based on a genomic profile, and it used to be called the Lung Metagene Predictor. Initial results suggest the LMS is good at identifying lung cancer patients’ chance of tumor recurrence. Because this new tool is still being developed it is considered experimental, and it is not yet available to doctors or patients. Use of the LMS is different from other genomic profiles because it does not help to choose a type of chemotherapy or a drug. Its value is in determining the likelihood of early stage NSCLC recurring after surgical removal of the tumor. This means that patients with a higher risk of recurrence could be offered additional treatment options.