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Recruiting NCT06512207

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

No phase Interventional NSCLC, Stage III NSCLC, Stage IV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Leuprorelin acetate + Sintilimab, Sintilimab.
Who it may be relevant to
Registry conditions: NSCLC, Stage III, NSCLC, Stage IV. Basic parameters: from 60 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Clinical Investigation on the Efficacy of Leuprorelin Acetate (Androgen Deprivation Therapy) Combined With Sintilimab (Anti-PD-1) in Advanced Lung Cancer

Overview

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.

Detailed description

Immune checkpoint blockades (ICBs) are widely used in the clinical treatment of lung cancer. Studies have shown that the quantity and function of tumor-infiltrating lymphocytes (TILs) are associated with the effectiveness of PD-1 inhibitors in treating advanced NSCLC. The thymus is crucial for the differentiation, development, and maturation of T cells. With age, thymic atrophy leads to immunosenescence, significantly affecting baseline anti-tumor immunity and responses to immunotherapies. 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. Therefore, this study aims to investigate the combination of Leuprorelin ADT and Sintilimab (anti-PD-1) therapy in patients with advanced lung cancer.

Interventions

  • Drug Leuprorelin acetate + Sintilimab
    Leuprolide, an FDA-approved GnRH agonist, reduces sex hormone production and is widely used in clinical practice.
  • Drug Sintilimab
    PD-1 inhibitor

Primary outcome measures

  • Number of Participants with Complete Response (CR) [Time frame: Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment]
  • Number of Participants with Partial Response (PR) [Time frame: Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment]
  • Number of Participants with Disease Progression (PD) [Time frame: Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment]
  • Number of Participants with Stable Disease (SD) [Time frame: Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment]
  • Quantity of Peripheral Blood Lymphocytes [Time frame: Laboratory evaluations are scheduled before treatment, at 3 weeks post-treatment, and at 6 weeks post-treatment]
  • Composition of Peripheral Blood Lymphocytes [Time frame: Laboratory evaluations are scheduled before treatment, at 3 weeks post-treatment, and at 6 weeks post-treatment.]
  • Status of Recent Thymic Emigrants (RTEs) [Time frame: Evaluations are scheduled before treatment, at 3 weeks post-treatment, and at 6 weeks post-treatment.]

Eligibility criteria

3.Inclusion Criteria:

  • 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.
  • Patients with adequate bone marrow function, no significant hepatic, renal, or coagulation dysfunction as per laboratory test criteria.
  • At least one tumor lesion meeting the following criteria:
  • No prior local treatments such as radiotherapy
  • Not biopsied during the screening period (if biopsy needed, baseline tumor assessment at least 14 days after the screening biopsy).
  • Measurable at baseline (longest diameter of the lesion ≥10 mm; For a lymph node, short diameter ≥15 mm).
  • If only one measurable lesion, no prior local treatments such as radiotherapy.
  • Ability to understand and voluntarily sign a written informed consent form.
  • Willingness to follow the study protocol and follow-up examinations.

Exclusion criteria

  • Exclusion of cases that do not meet the inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University — Zhengzhou

Identifiers

NCT: NCT06512207 · NSFC-32230037

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗