Health TrialsbyHealthPanel

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

ConditionsNSCLC, Stage IIINSCLC, Stage IV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age60+
SponsorJinzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Exclusion of cases that do not meet the inclusion criteria

Trial design

Design model

Parallel

Treatments tested in this trial

  • Leuprorelin acetate + Sintilimab

    Drug

    Leuprolide, an FDA-approved GnRH agonist, reduces sex hormone production and is widely used in clinical practice.

  • Sintilimab

    Drug

    PD-1 inhibitor

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Conventional Treatment GroupActive comparator 1 intervention
Group B: Conventional Treatment Combined with Leuprolide GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment
2

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

Time frame
Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment
3

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.

Time frame
Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment
4

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.

Time frame
Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jinzhou Medical University

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Collaborator

Source ClinicalTrials.gov
Apply now