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

NCT06512207 | Recruiting DMC

• 1 other identifier: NSFC-32230037
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC, Stage III; NSCLC, Stage IV

Keywords

Androgen Deprivation Therapy （ADT）; Leuprorelin acetate; NSCLC; PD-1 inhibitor

Outcome Measures

Primary Outcomes (7)

• 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.

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

• 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

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

• 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.

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

• 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.

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

• Quantity of Peripheral Blood Lymphocytes

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

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

• Composition of Peripheral Blood Lymphocytes

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

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

• Status of Recent Thymic Emigrants (RTEs)

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

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

Study Arms (2)

Conventional Treatment Group

ACTIVE COMPARATOR

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

Drug: Sintilimab

Conventional Treatment Combined with Leuprolide Group

EXPERIMENTAL

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

Drug: Leuprorelin acetate + Sintilimab

Interventions

Leuprorelin acetate + Sintilimab DRUG

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

Also known as: Leuprolide

Conventional Treatment Combined with Leuprolide Group

Sintilimab DRUG

PD-1 inhibitor

Also known as: Anti-PD-1 monoclonal

Conventional Treatment Group

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Jinzhou Medical University: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Leuprolide; sintilimab; spartalizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Yu Zhang, Professor

  Jinzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wangzhi Wei

CONTACT

(86)13941620158; weiwangzhi@jzmu.edu.cn

Shuangning Yang

CONTACT

(86)15138955506

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 80 cases of stage III or IV NSCLC are randomly divided into two groups of 40 cases each. The control group is to receive conventional treatments (Chemotherapy + PD-1 Monoclonal Antibody), while the experimental group is to receive conventional treatments combined with Leuprorelin acetate.

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 22, 2024
• Study Start: December 3, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)