Barriers to Optimal Care

Barriers to Optimal Care studies focus on understanding structural, patient-specific, and physician-specific barriers to accessing optimal care, such as access to comprehensive biomarker testing and clinical trials, with the ultimate goal of developing solutions to mitigate these barriers.

Lung cancer is not a single disease; rather, it is a collection of different subtypes of cancer. It is divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

NSCLC, diagnosed in about 85% of people with lung cancer, is the most common subtype of lung cancer. The complex molecular biology of this disease requires personalized management plans for patients. Targeted therapies have become a major component of the treatment arsenal for NSCLC patients. At present, at least 20 driver mutations in NSCLC have been identified. Currently, FDA-approved drugs for seven NSCLC mutations (EGFR, ALK, ROS1, BRAF V600E, NTRK, RET, and MET) are already in clinical practice, and several targeted therapies specific to other mutations are in clinical development.

Access to high-quality, timely comprehensive biomarker testing (such as NGS testing) when a patient is newly diagnosed or at recurrence or progression is instrumental for matching patients to the appropriate targeted therapy and advancing precision medicine. In addition to targeted therapies, immunotherapies are becoming the mainstay of first-line treatment of non-mutation-driven NSCLCs and SCLC. Given the complexity of care, it is important to document and understand barriers to accessing care with the goal of mitigating these barriers.

Another route to accessing new therapies is participating in clinical trials. Clinical trials, studies that test how new methods of screening, prevention, diagnosis, or treatment of a disease work in people, are a critical component of the drug development process. They are also a source of access to lifesaving treatments, such as new drugs or combinations of new drugs while they are still in the drug development process and not approved by the FDA (the US Food and Drug Administration).

Both the American Society of Clinical Oncology and the National Comprehensive Cancer Network, two professional societies that issue guidelines for cancer care in the United States, recommend clinical trials as standard of care for cancer therapy. However, participation in lung cancer clinical trials continues to be suboptimal. It is therefore important to document what structural, patient-specific, and physician-specific barriers impede lung cancer patients from participating in clinical trials.