RADICAL-IO: thRee Cycles of immunotherApy Without raDical Therapy In mediCALly InOperable Stage I Non-small Cell Lung Cancer
brief summary
Traditionally, chemotherapy and/or immunotherapy are combined with surgery or radiotherapy to cure patients with lung cancer. However, some patients treated with immunotherapy appear to be cured before surgery or radiotherapy. In this study, we will select patients with a high chance to respond to immunotherapy. These patients will be treated with immunotherapy alone, thereby evaluating whether these patients can be cured without surgery or radiotherapy.
detailed description
Early-stage non-small cell lung cancer (NSCLC) patients with a pathological complete response (pCR) to neoadjuvant chemoimmunotherapy are potentially already cured before the local radical treatment is administered. However, treatment de-escalation in these patients is unfeasible since pCR detection before local radical treatment is unreliable. We propose to evaluate whether we can safely omit local radical therapy after immunotherapy in selected patients with stage Ia NSCLC with high probability of immunotherapy benefit.
Participants receive three cycles of 350 milligrams of cemiplimab intravenously every three weeks followed by a radiological and metabolic response evaluation with respectively CT and \[18F\]FDG-PET. Thereafter patients will enter the follow-up phase where response will be closely monitored with CT scans 3-monthly. Additionally, blood will be collected for ctDNA analysis at baseline, during treatment with cemiplimab and follow-up will be collected. According to standard of care, patients will undergo a \[18F\]FDG-PET scan if progressive disease is suspected. Participants with disease recurrence will be treated off-study at the discretion of the treating physician.