HGXJT plus immune therapy for non-small cell lung cancer that has spread to the bones

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 is a double-blind, randomized trial that gives enrolled patients either HGXJT or a placebo alongside standard ICI-based treatment for the first 4–6 treatment cycles. Eligible participants have histologically confirmed non-small cell lung cancer with bone metastases, are EGFR/ALK wild type, and have not previously received PD-1 inhibitors. The study monitors safety and measures efficacy outcomes during and after the combination treatment period. The lead sponsor is Guangzhou University of Traditional Chinese Medicine and the treatment site is Guangdong Provincial Hospital of Traditional Chinese Medicine in Guangzhou.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with non-small cell lung cancer diagnosed by histopathology or cytopathology.
2. Presence of bone metastases.
3. EGFR/ALK gene wild type.
4. No prior treatment with PD-1 inhibitors (combination or monotherapy)
5. Those who have not received prior antitumor therapy or have not received further antitumor therapy after failure of first-line antitumor therapy.
6. PS score (ECOG) ≤ 2 points
7. Normal hepatic and renal function.

   Normal hepatic function: total serum bilirubin level ≤ 1.5 times of the upper limit of normal value(ULN), serum serum aspartate aminotransferase(AST) \& alanine aminotransferase(ALT) ≤ 2.5 times ULN

   Normal renal function: serum creatinine ≤ 1.5 mg/dl (133 μmol/L) and/or creatinine clearance ≥ 60 ml/min.
8. Presence of at least one assessable lesion.
9. Signed informed consent, patient willing to accept this regimen, able to adhere to the medication, and good compliance.

Exclusion Criteria:

1. Unable to complete the baseline assessment form
2. Combination of other serious illnesses, including uncontrolled active infection, severe electrolyte disturbances, and significant bleeding tendencies.
3. Pregnant or lactating women.
4. Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs.
5. Combination of other uncontrolled tumors.
6. Combination of severe brain or mental illness that affects the patient's ability to self-report.
7. Combined organ transplant history (including bone marrow autotransplantation and peripheral stem cell transplantation).
8. Those who are legally incompetent and whose medical or ethical reasons affect the continuation of the research.

Where it's running

• Guangdong Provincial Hospital of Traditional Chinese Medicine
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Haibo Zhang, Professor — Guangdong Provincial Hospital of Traditional Chinese Medicine
• Study coordinator: Wenjie Zhao, Dr
• Email: 20209120019@stu.gzucm.edu.cn
• Phone: 8602081887233

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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.