Durvalumab With Radiochemotherapy and Stereotactic Radiotherapy for Extensive-Stage Small-Cell Lung Cancer

What this Trial Is About

Researchers are investigating a new treatment approach for patients with extensive-stage small-cell lung cancer ES-SCLC who have a limited number of tumor lesions, known as oligometastatic disease. This open-label, single-arm phase II trial aims to evaluate the effectiveness of combining immunotherapy with durvalumab alongside radiochemotherapy, followed by durvalumab maintenance therapy combined with stereotactic radiotherapy. The study focuses on patients who have already undergone two cycles of platinumetoposidedurvalumab therapy and have shown stable disease or partial response. Participants will receive radiochemotherapy targeting the primary tumor and mediastinal lymph node metastases, with durvalumab given concurrently every three weeks along with chemotherapy cycles of platinum and etoposide. Radiotherapy is delivered in daily fractions up to a total dose of 63 Gy using advanced techniques. After this, during durvalumab maintenance therapy, stereotactic radiotherapy will be applied to up to four additional tumor sites. The sequence of radiotherapy may be adjusted if urgent treatment of symptomatic metastases, such as brain or vertebral lesions, is needed. Throughout the study, participants will undergo assessments to monitor disease progression and response to treatment. Researchers will evaluate progression-free survival at 12 months as the primary outcome and overall survival at 12 months as a secondary outcome. Patients will be closely followed with scheduled visits, examinations, and imaging as needed to track treatment effects and safety. The study is expected to continue until December 2027, with ongoing monitoring during and after treatment.

Durvalumab With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Oligometastatic ES-SCLC