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

NCT ID: NCT06512207

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-03
• Study Completion Date: 2026-06-30

Brief 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.

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.

Conditions

NSCLC, Stage III; NSCLC, Stage IV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Treatment Group

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

Group Type: ACTIVE_COMPARATOR

Sintilimab

Intervention Type: DRUG

PD-1 inhibitor

Conventional Treatment Combined with Leuprolide Group

40 cases in this group to receive the standard conventional therapy (Chemotherapy + PD-1 Monoclonal Antibody) combined with Leuprorelin acetate, 3.75 mg

Group Type: EXPERIMENTAL

Leuprorelin acetate + Sintilimab

Intervention Type: DRUG

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

Interventions

Leuprorelin acetate + Sintilimab

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

Intervention Type: DRUG

Sintilimab

PD-1 inhibitor

Intervention Type: DRUG

Other Intervention Names

Leuprolide; Anti-PD-1 monoclonal

Eligibility Criteria

Inclusion Criteria

1. Male patients aged ≥60 years.

2. ECOG performance status score of 0 ~1.

3. Expected survival time of more than 3 months.

4. Histologically or cytologically diagnosed advanced lung cancer according to the TNM staging system established by AJCC.

5. Patients who have not previously received any anti-PD-1 treatment.

6. Patients with adequate bone marrow function, no significant hepatic, renal, or coagulation dysfunction as per laboratory test criteria.

7. 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.

8. Ability to understand and voluntarily sign a written informed consent form.

9. Willingness to follow the study protocol and follow-up examinations.

• Minimum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Jinzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yu Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

Jinzhou Medical University

Locations

The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wangzhi Wei

Role: CONTACT

weiwangzhi@jzmu.edu.cn

(86)13941620158

Shuangning Yang

Role: CONTACT

(86)15138955506

Facility Contacts

Shuangning Yang

Role: primary

(86)15138955506

Other Identifiers

NSFC-32230037

Identifier Type: -

Identifier Source: org_study_id