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

What Was Tested

In this not phased trial, researchers set out to test Leuprolide.

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.

It had two arms (groups): Conventional Treatment Group (active comparator) and Conventional Treatment Combined with Leuprolide Group (experimental).

40 cases in this group to receive the standard conventional treatment (Chemotherapy + PD-1 Monoclonal Antibody).

The registry classes the interventions as drug.

More on the Plan

Immune checkpoint blockades (ICBs) are widely used in the clinical treatment of lung cancer.

The thymus is crucial for the differentiation, development, and maturation of T cells.

Preliminary findings have indicated that androgen deprivation therapy (ADT) not only directly induces apoptosis in prostate cancer cells but also may exert anti-tumor effects by promoting thymic regeneration.

Furthermore, anti-tumor synergism has been identified by combining ADT with anti-PD-1 immunotherapy for androgen-independent tumors.

Who Took Part

The registry lists 80 planned participants were the target.

It was open to men only aged from 60 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male patients aged ≥60 years. ECOG performance status score of 0 \~1. Expected survival time of more than 3 months. Histologically or cytologically diagnosed advanced lung cancer according to the TNM staging system established by AJCC. Patients who have not previously received any anti-PD-1 treatment.

The full record lists 14 inclusion and 1 exclusion criteria; among the exclusions: exclusion of cases that do not meet the inclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

The Leuprolide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2023-12-03 with completion listed for 2025-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants with Complete Response (CR). Number of Participants with Partial Response (PR). Number of Participants with Disease Progression (PD).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Leuprolide in 80 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.