Combining hormone therapy and immunotherapy for advanced lung cancer

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

This study is testing if combining hormone therapy with a type of immunotherapy can help older men with advanced lung cancer respond better to treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 60 Years and up
• Sex: Male
• Sponsor: Jinzhou Medical University (Academic / other)
• Drugs / interventions: Sintilimab, immunotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06512207 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of combining androgen deprivation therapy (ADT) with anti-PD-1 therapy in patients with advanced non-small cell lung cancer (NSCLC). The approach aims to enhance anti-tumor immunity by promoting thymic regeneration, which may improve the effectiveness of immunotherapy. Patients will receive Leuprorelin acetate for ADT alongside Sintilimab, an anti-PD-1 agent, to evaluate the synergistic effects on tumor response. The study focuses on male patients aged 60 and older who have not previously undergone anti-PD-1 treatment.

Who should consider this trial

Good fit: Ideal candidates are male patients aged 60 years or older with advanced lung cancer who have not received prior anti-PD-1 treatment.

Not a fit: Patients with significant hepatic, renal, or coagulation dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this combination therapy could significantly improve treatment outcomes for patients with advanced lung cancer.

How similar studies have performed: While the combination of ADT and anti-PD-1 therapy is a novel approach, preliminary findings suggest potential benefits in similar contexts, though further validation is needed.

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

Where this trial is running

Zhengzhou, Henan

• The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Yu Zhang, Professor — Jinzhou Medical University
• Study coordinator: Wangzhi Wei

Conditions NSCLC, Stage III; NSCLC, Stage IV; Androgen Deprivation Therapy （ADT）; Leuprorelin acetate; NSCLC; PD-1 inhibitor