Phase II Study of Adding Biologically Guided Radiation Therapy and Stereotactic Body Radiation Therapy to Osimertinib for EGFR Positive Oligoprogressive Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the combination of biologically guided radiation therapy BgRT and stereotactic body radiation therapy SBRT together with the drug osimertinib for treating patients with EGFR positive non-small cell lung cancer NSCLC that has spread to a limited number of sites oligoprogressive disease. This phase II trial aims to estimate how many patients benefit from adding BgRTSBRT to osimertinib over six months, while also assessing treatment tolerability, survival, quality of life, and tumor control. Participants continue taking osimertinib orally daily unless they experience unacceptable side effects. They receive BgRTSBRT radiation every other day for five treatments targeting tumor sites with high precision. After initial radiation, patients are monitored through imaging scans and blood samples, with additional radiation therapy possible if new progression occurs. Treatment continues as long as there are fewer than five progressing sites, no unacceptable toxicity, and osimertinib is not stopped for more than four weeks. Throughout the study, patients undergo CT or PETCT scans and blood collections. Follow-up visits occur one week after radiation, then at three, six, and twelve months, with an additional year of monitoring. Researchers measure disease control rate at six months as the primary outcome, along with survival, side effects, quality of life changes, tumor metabolic activity, and time to treatment failure. The total study duration allows observation up to two years after enrollment.

Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive Oncogenic Positive Non-Small Cell Lung Carcinoma