NSCLC, Stage IIINCT06512207
A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer
A study testing Leuprorelin acetate + Sintilimab and Sintilimab in people with NSCLC, Stage III and NSCLC, Stage IV, run by Jinzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- NSCLC, Stage III, NSCLC, Stage IV
- What is being tested?
- Leuprorelin acetate + Sintilimab and Sintilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Exclusion of cases that do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shuangning Yang contact
China1 site, 1 recruiting
- Recruiting
The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Shuangning Yang, (86)15138955506
Liping Wang
About this study
Official title: A Clinical Investigation on the Efficacy of Leuprorelin Acetate (Androgen Deprivation Therapy) Combined With Sintilimab (Anti-PD-1) 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.
Read the 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
- Being tested
- Leuprorelin acetate + Sintilimab, Sintilimab
- Keywords
- Androgen Deprivation Therapy （ADT）, Leuprorelin acetate, NSCLC, PD-1 inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprorelin acetate + SintilimabDrug
Also called Leuprolide
Leuprolide, an FDA-approved GnRH agonist, reduces sex hormone production and is widely used in clinical practice.
SintilimabDrug
Also called Anti-PD-1 monoclonal
PD-1 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment Group | Active comparator | 40 cases in this group to receive the standard conventional treatment (Chemotherapy + PD-1 Monoclonal Antibody) Receives: 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 Receives: Drug: Leuprorelin acetate + Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Evaluations are scheduled before treatment, at 3 weeks post-treatment, and at 6 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start3 Dec 2023
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC, Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Zhang, Jinzhou Medical University
- Investigators
- Yu Zhang, Professor, Principal investigator, Jinzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512207
- Sponsor's protocol ID
- NSFC-32230037
- Status last verified
- Aug 2025
- First submitted
- 6 Jul 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We currently do not plan to share individual patient data (IPD) with other researchers due to confidentiality concerns and ethical restrictions. Additionally, the data collected in this study are considered proprietary and are crucial for ongoing and future research projects.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation on the Efficacy of Leuprorelin Acetate (Androgen Deprivation Therapy) Combined With Sintilimab (Anti-PD-1) in Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT06512207
- Acronym / sponsor ID
- NSFC-32230037
- Conditions
- NSCLC, Stage III, NSCLC, Stage IV
- Keywords
- Androgen Deprivation Therapy （ADT）, Leuprorelin acetate, NSCLC, PD-1 inhibitor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jinzhou Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 3 Dec 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment Group | Active comparator | Drug: Sintilimab40 cases in this group to receive the standard conventional treatment (Chemotherapy + PD-1 Monoclonal Antibody) |
| Conventional Treatment Combined with Leuprolide Group | Experimental | Drug: Leuprorelin acetate + Sintilimab40 cases in this group to receive the standard conventional therapy (Chemotherapy + PD-1 Monoclonal Antibody) combined with Leuprorelin acetate, 3.75 mg |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Exclusion of cases that do not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leuprorelin acetate + SintilimabAlso: LeuprolideLeuprolide, an FDA-approved GnRH agonist, reduces sex hormone production and is widely used in clinical practice. | Drug | Conventional Treatment Combined with Leuprolide Group |
| SintilimabAlso: Anti-PD-1 monoclonalPD-1 inhibitor | Drug | Conventional Treatment Group |
Primary outcome
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.
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
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.
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.
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No. We currently do not plan to share individual patient data (IPD) with other researchers due to confidentiality concerns and ethical restrictions. Additionally, the data collected in this study are considered proprietary and are crucial for ongoing and future research projects.
Related trials for NSCLC, Stage III
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
RecruitingPhase 3
A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.
Non Small Cell Lung Cancer
Not yet recruiting
Moderately Hypofractionated Versus Conventional Chemoradiotherapy With Consolidation Immunotherapy in Patients With Unresectable, Non-Targetable Stage III Non Small Cell Lung Cancer (NSCLC)
Stage III NSCLC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shuangning Yang contact
Yu Zhang, Professor principal investigator
Jinzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leuprorelin acetate + Sintilimab and Sintilimab in people with NSCLC, Stage III and NSCLC, Stage IV, run by Jinzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wangzhi Wei ((86)13941620158, weiwangzhi@jzmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Complete Response (CR) (time frame: Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.