Evaluating Leuprorelin Acetate Combined With Sintilimab Therapy for Advanced Lung Cancer in Men Aged 60 and Older

What this Trial Is About

Researchers are evaluating the combination of Leuprorelin androgen deprivation therapy ADT and Sintilimab, an anti-PD-1 immunotherapy, in male patients aged 60 and older with advanced lung cancer. The study aims to explore how ADT may promote thymic regeneration to improve anti-tumor immunity and enhance responses to immunotherapies in advanced non-small cell lung cancer NSCLC. This investigation is sponsored by Jinzhou Medical University and focuses on patients with stage III or IV NSCLC who have not previously received anti-PD-1 treatment. Participants are randomly assigned to one of two groups one group receives standard chemotherapy combined with a PD-1 monoclonal antibody, while the other group receives the same standard treatment plus Leuprorelin acetate at a dose of 3.75 mg. The study treatment is administered according to established schedules, with evaluations planned at 6, 12, and 18 weeks post-treatment to assess response. Laboratory tests to measure peripheral blood lymphocytes and recent thymic emigrants are conducted before treatment and at 3 and 6 weeks after treatment. Throughout the study, participants will undergo clinical assessments, tumor response evaluations, and blood tests to monitor immune cell populations. Efficacy is measured by the number of participants achieving complete response, partial response, stable disease, or disease progression. The study also observes thymic output and immune status changes to understand the treatment impact. Participants are expected to comply with follow-up visits and evaluations, with overall survival and performance status monitored to assess treatment effects and safety over the course of the trial.

A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer