Phase II Study of Adding Cemiplimab to Sequential Hypofractionated Chemoradiotherapy in Unfit or Elderly Patients with Unresectable Stage III Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are investigating whether adding cemiplimab, an immunotherapy drug, to neoadjuvant chemotherapy and sequential hypofractionated radiotherapy can improve survival outcomes for unfit or elderly patients with unresectable stage III non-small cell lung cancer NSCLC. The study compares the benefits of neoadjuvant chemotherapy alone versus chemotherapy combined with cemiplimab, followed by radiotherapy and maintenance immunotherapy. This phase II trial aims to assess both the effectiveness and tolerance of these treatments. Participants are randomly assigned to one of two groups one receiving neoadjuvant chemotherapy with carboplatin and paclitaxel alone, and the other receiving the same chemotherapy combined with cemiplimab. Both groups then undergo curative hypofractionated radiotherapy. Following radiotherapy, all participants receive maintenance immunotherapy with cemiplimab every three weeks for 12 months. The neoadjuvant chemotherapy cycles last for three cycles of four weeks each, and radiotherapy consists of 55 Gy over 20 fractions. During the trial, participants will be monitored through scheduled visits and laboratory tests to evaluate disease progression, response rates, survival, and treatment-related toxicity. Quality of life will be assessed using specific questionnaires for lung cancer. The primary outcome is progression-free survival over about 18 months, with secondary outcomes including overall survival and toxicity rates. Participants adherence and safety will be closely tracked throughout the study, which extends up to early 2032.

Adjuvant Chemotherapy +/- Cemiplimab and Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Stage III Lung Cancer