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NCT Number: NCT06512207

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

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.

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Key information

Conditions

NSCLC, Stage III Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms NSCLC, Stage IV Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

60 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location status: Recruiting

Location contact

Liping Wang

PRINCIPAL_INVESTIGATOR

Shuangning Yang

CONTACT

(86)15138955506

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leuprorelin acetate + Sintilimab

Drug

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

Other names: Leuprolide

Sintilimab

Drug

PD-1 inhibitor

Other names: Anti-PD-1 monoclonal

Primary outcomes

  1. Number of Participants with Complete Response (CR)

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

    Disappearance of all target lesions, with nodular diseases excluded and target nodules reduced to <10mm in short axis.

  2. Number of Participants with Partial Response (PR)

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

    Reduction of at least 30% in the sum of diameters of all measurable target lesions compared to baseline

  3. Number of Participants with Disease Progression (PD)

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

    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.

  4. Number of Participants with Stable Disease (SD)

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

    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.

  5. Quantity of Peripheral Blood Lymphocytes

    Time frame: Laboratory evaluations are scheduled before treatment, at 3 weeks post-treatment, and at 6 weeks post-treatment

    Assessment of peripheral blood lymphocyte quantity, comparing patients before and after a treatment cycle

  6. Composition of Peripheral Blood Lymphocytes

    Time frame: Laboratory evaluations are scheduled before treatment, at 3 weeks post-treatment, and at 6 weeks post-treatment.

    Assessment of peripheral blood lymphocyte composition, comparing patients before and after a treatment cycle

  7. Status of Recent Thymic Emigrants (RTEs)

    Time frame: Evaluations are scheduled before treatment, at 3 weeks post-treatment, and at 6 weeks post-treatment.

    Assessment of the status of Recent Thymic Emigrants (RTEs), comparing patients before and after a treatment cycle

Study contacts

Contact information is provided by the study sponsor or research team.

Shuangning Yang

CONTACT

(86)15138955506

Wangzhi Wei

CONTACT

[email protected]

(86)13941620158

Sponsors and collaborators

Lead sponsor

Jinzhou Medical University

Other

Collaborators

  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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