Study of DNA Damage Repair Inhibitors Combined With Radiotherapy and Durvalumab in Non Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating new DNA damage repair inhibitors DDRis combined with radiotherapy for patients with stage IIB to IIIB non-small cell lung cancer NSCLC in this Phase IB study. The purpose is to find the recommended dose and safety of DDRis given with a fixed dose of curative radiotherapy, followed by up to 12 months of consolidation durvalumab immunotherapy in some groups. The study uses a specialized method to monitor dose-limiting toxicities over 13.5 months to guide safe dosing decisions. Participants receive radiotherapy administered in 30 daily fractions of 2Gy each, totaling 60Gy Monday to Friday. Some groups also receive oral DDRi drugs such as Olaparib, AZD1390, Ceralasertib, or AZD5305 alongside radiotherapy. Selected groups receive up to 12 months of durvalumab immunotherapy after radiotherapy. No placebo is used both patients and doctors know the assigned treatments. One study arm was discontinued. During the study, patients are closely followed to monitor side effects, cancer response, and treatment compliance. Blood samples are collected to track progress and explore which patients may benefit most. Researchers assess dose-limiting toxicities up to 13.5 months after radiotherapy start and evaluate safety, response, disease control, survival, and quality of life up to two years post-treatment. Participation lasts through treatment and follow-up periods for comprehensive monitoring.

A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC