Risk vs. Benefit: Clinical Trial Aims to Identify Patients with Early-Stage NSCLC Who May Not Need Immunotherapy After Surgery

Many patients with early-stage non-small cell lung cancer (NSCLC) are treated post-surgery with the monoclonal antibody durvalumab (brand name Imfinzi) — an FDA-approved regimen. A PD-L1 inhibitor, durvalumab is designed to prevent cancer cells from growing and metastasizing. But for patients at low risk of recurrence, does the potential benefit merit the possible side effects of immunotherapy? A phase 3 cooperative group trial of the SWOG Cancer Research Network, now underway at Roswell Park Comprehensive Cancer Center, aims to identify patients who might not need it.

“It’s unclear at this point which patients, if any, benefit from that year of immunotherapy after experiencing complete pathologic complete response with neoadjuvant chemoimmunotherapy, where the overall risk of recurrence is very low,” says Bailey Fitzgerald, MD, Assistant Professor of Oncology in the Department of Medicine at Roswell Park. Dr. Fitzgerald is Site Principal Investigator of the study (NCT06498635), which is now enrolling patients.

Participants will be randomized to one of two groups — one undergoing surveillance alone and the other receiving adjuvant durvalumab. The study will compare disease-free, event-free and overall survival in the two groups.

“This trial is important because if a low-risk population would do just as well without it, we would rather save them the time and toxicity of this additional year of treatment,” says Dr. Fitzgerald.

Roswell Park is the only center in upstate New York State offering the clinical trial, called INSIGHT, which is sponsored by the National Cancer Institute.