Study of Personalized Consolidation Treatment with Durvalumab, Tremelimumab, and Chemotherapy in Stage III Unresectable Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are studying how combining the standard treatment durvalumab with tremelimumab and additional chemotherapy affects the number of circulating cancer cells in the blood of people with stage III non-small cell lung cancer NSCLC. The study focuses on patients with unresectable stage III NSCLC who have detectable tumor DNA in their blood and have already received chemoradiotherapy and immunotherapy. This phase 3 trial aims to understand whether this combination can reduce minimal residual disease and improve survival outcomes. Participants with detectable tumor DNA Cohort 1 will receive four cycles of platinum-based chemotherapy carboplatin with either pemetrexed or paclitaxel, tremelimumab every 21 days, and durvalumab every 21 days. Those with undetectable tumor DNA Cohort 2 will receive standard durvalumab treatment every two weeks for one year. Imaging scans such as PETCT or CT of the chest will be performed every 12 weeks to monitor disease status. If no progression or significant side effects occur, patients will continue durvalumab to complete one year of treatment. During the study, participants will have blood drawn to measure circulating tumor DNA levels and undergo regular imaging to assess cancer progression. Researchers will evaluate changes in tumor DNA after chemotherapy, overall survival, progression-free survival, and adverse events related to the treatments. The study includes safety monitoring for up to 13 months and follows patients for up to two years to assess long-term outcomes. Participants will be involved in treatment and follow-up visits over this period to support comprehensive evaluation of the therapies.

Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC