The National Cancer Institute (NCI) is making it clear that the era of genomics is fundamentally changing how we understand cancer and how we conduct cancer research. In light of this shift in our understanding, the NCI has not only launched a new Center for Cancer Genomics, but it has also started a Provocative Questions initiative, which tries to spur scientists to ask new research questions in new ways. The NCI has sponsored the following clinical trials that experiment with new models for clinical research:
Exceptional Responders Initiative: Most drugs that enter Phase 2 trials never go on to Phase 3 because they don’t work in enough patients. Yet as many as 10 percent of patients in these studies show exceptional response to the experimental treatment. This initiative will analyze the preserved tumor samples from these patients. The hope is to understand the molecular reasons for these exceptional responses, leading to more targeted treatments.
NCI MATCH (Molecular Analysis for Therapy Choice): This trial will focus on patients with solid tumors who have not responded to treatment. The study will assign experimental drugs to patients based on the molecular profile of their tumors. Approximately 3,000 patients will be screened, and 15 to 30 drugs will be studied in the trial.
ALCHEMIST (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial): This trial will screen patients who have had surgery for lung adenocarcinoma, looking for relatively rare mutations in EGFR and ALK genes. Those patients found to have the mutations will be enrolled in trials of agents targeting those particular alterations.
Advanced Lung SCCA Master Protocol: Each year, researchers will pool tumor samples from as many as 1,000 patients with advanced squamous cell lung cancer and then test agents that target mutations in parallel. Agents will be dropped if they don’t work and new ones will be added, without having to start all over.
For a more in-depth look at how researchers are rethinking clinical trials, see our story in the latest issue of Genome.