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Trial Title:
A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer
NCT ID:
NCT06512207
Condition:
NSCLC, Stage III
NSCLC, Stage IV
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Leuprolide
Conditions: Keywords:
Androgen Deprivation Therapy （ADT）
Leuprorelin acetate
NSCLC
PD-1 inhibitor
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Leuprorelin acetate + Sintilimab
Description:
Leuprolide, an FDA-approved GnRH agonist, reduces sex hormone production and is widely
used in clinical practice.
Arm group label:
Conventional Treatment Combined with Leuprolide Group
Other name:
Leuprolide
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
PD-1 inhibitor
Arm group label:
Conventional Treatment Group
Other name:
Anti-PD-1 monoclonal
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.
Criteria for eligibility:
Criteria:
3.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.
Exclusion Criteria:
- Exclusion of cases that do not meet the inclusion criteria
Gender:
Male
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuangning Yang
Phone:
(86)15138955506
Investigator:
Last name:
Liping Wang
Email:
Principal Investigator
Start date:
December 3, 2023
Completion date:
June 2026
Lead sponsor:
Agency:
Jinzhou Medical University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Source:
Jinzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06512207
