Two large-scale precision medicine clinical trials for lung cancer are underway in the United States, and offer potential new treatment options for patients with specific genetic mutations.
Lung cancer patients are now being given the opportunity to participate in precision medicine clinical trials on a national scale, which may benefit the largest number of patients with the disease to date.
Currently, patients are being enrolled in two national clinical trials: LUNG-MAP and ALCHEMIST. The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (ALCHEMIST) are a group of clinical trials for patients with certain types of early-stage non–small cell lung cancer (NSCLC) that has been treated surgically. The ALCHEMIST also involves genetic profiling of tumor specimens and matching patients with specific gene mutations to trials evaluating drugs that target those specific mutations. Patients will already have had surgery and adjuvant therapy before proceeding with the ALCHEMIST treatments.
Trial site investigator Ronald Alvarez, MD, a professor at the University of Alabama Birmingham (UAB) Division of Gynecologic Oncology, said involvement in these types of clinical trials provides better access for patients to promising drugs and at the same time provides the infrastructure needed to test investigational drugs. He said with these trials all the patients are able to receive the best possible treatment, which might include various chemotherapy options or new drugs designed to attack their particular cancer based upon their tumor’s specific characteristics.
LUNG-MAP is a first-of-its-kind clinical trial that uses a multidrug, targeted screening approach to match patients with substudies testing investigational new treatments based on unique tumor profiles. State-of-the-art genomic profiling is used to determine the genetic alterations or mutations driving each patient’s cancer. Instead of having to undergo multiple diagnostic tests to determine eligibility for many different studies, enrollees are tested just once according to a master protocol and assigned to one of five different trial substudies. Each substudy tests a different drug from a different developer.
Lung cancer specialist Francisco Robert, MD, a professor in the UAB Division of Hematology and Oncology, said patients with early-stage lung cancer should be encouraged to enroll in these trials. He said the primary objective is to learn whether a targeted cancer therapy that is matched to the genomic makeup of a patient’s lung cancer tumor is more effective than the current standard therapy in halting or reversing the progress of the disease and extending the patient’s life.
Lung cancer is the second most common cancer in the United States and accounts for about 13% of all new cancers. The American Cancer Society estimates that in 2015 about 221,200 new cases of lung cancer will occur and an estimated 158,040 patients will die of this disease.