Phase II Study of Monalizumab Combined with Durvalumab and Chemotherapy for Treatment of Extensive and Limited Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating treatments for small cell lung cancer SCLC in two groups one with extensive-stage disease and one with limited-stage disease. The study aims to assess the combination of durvalumab and monalizumab with chemotherapy and radiation in different settings. This Phase II trial investigates how this therapy works for patients with newly diagnosed SCLC or those who have received limited prior treatment, focusing on progression-free survival and safety over 24 months. In the extensive-stage group, participants receive a platinum drug carboplatin or cisplatin, etoposide, durvalumab, and monalizumab every 3 weeks for 4 cycles. After that, maintenance treatment with durvalumab and monalizumab is given every 4 weeks until disease progression or other stopping reasons. The limited-stage group receives durvalumab and monalizumab after completing chemo-radiation with a platinum drug and etoposide, continuing treatment every 4 weeks for up to 2 years or until stopping criteria are met. A safety lead-in phase will confirm the dosing regimen for monalizumab. Participants will undergo regular evaluations including laboratory tests to confirm organ function, imaging to measure disease status, and monitoring for side effects. Researchers will track progression-free survival at one year and overall survival up to 24 months. Safety and tolerability will be closely monitored throughout treatment. Study visits involve intravenous infusions and assessments according to treatment cycles, with follow-up continuing until disease progression, unacceptable side effects, or participant withdrawal.

MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer