Combining hormone therapy and immunotherapy for advanced lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: weiwangzhi@jzmu.edu.cn
• Phone: (86)13941620158

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.