A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer
NCT Number: NCT06512207
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: NSCLC, Stage III|NSCLC, Stage IV
Interventions: DRUG: Leuprorelin acetate + Sintilimab|DRUG: Sintilimab
Sponsor: Jinzhou Medical University
Collaborators: The First Affiliated Hospital of Zhengzhou University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12-03
Completion Date: 2026-06
Locations: The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China

Summary:
Androgen Deprivation Therapy (ADT) triggers thymic revitalization and increases thymic output, enhancing baseline anti-tumor immunity and responses to immunotherapies. Anti-tumor synergism has been identified by combining ADT with anti-PD-1 immunotherapy for androgen-independent tumors. This study is to investigate the combination of Leuprorelin ADT and Sintilimab (anti-PD-1) therapy in patients with advanced lung cancer.

Primary Outcome Measures: Number of Participants with Complete Response (CR), Disappearance of all target lesions, with nodular diseases excluded and target nodules reduced to \<10mm in short axis., Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment|Number of Participants with Partial Response (PR), Reduction of at least 30% in the sum of diameters of all measurable target lesions compared to baseline, Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment|Number of Participants with Disease Progression (PD), A 20% increase in the sum of the diameters of all measurable target lesions over the entire study period (using the smallest baseline value if it is the smallest), coupled with an absolute increase in the sum of diameters of at least 5mm. The appearance of one or more new lesions is also considered disease progression., Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment|Number of Participants with Stable Disease (SD), Lesion reduction not meeting PR criteria nor sufficient increase for PD, falling in between these two endpoints. The minimum sum of diameters during the study period can be used as a reference., Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment|Quantity of Peripheral Blood Lymphocytes, Assessment of peripheral blood lymphocyte quantity, comparing patients before and after a treatment cycle, Laboratory evaluations are scheduled before treatment, at 3 weeks post-treatment, and at 6 weeks post-treatment|Composition of Peripheral Blood Lymphocytes, Assessment of peripheral blood lymphocyte composition, comparing patients before and after a treatment cycle, Laboratory evaluations are scheduled before treatment, at 3 weeks post-treatment, and at 6 weeks post-treatment.|Status of Recent Thymic Emigrants (RTEs), Assessment of the status of Recent Thymic Emigrants (RTEs), comparing patients before and after a treatment cycle, Evaluations are scheduled before treatment, at 3 weeks post-treatment, and at 6 weeks post-treatment.