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

Efficacy and Safety of Bone-protecting and Mass-dispersesing Decoction (HuGuXiaoJiTang, HGXJT) Combining With ICIs in Bone Metastatic NSCLC Patients

This trial tests whether adding HGXJT, a traditional Chinese herbal formula, to standard immune checkpoint inhibitor treatment helps people with non-small cell lung cancer that has bone metastases.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangzhou University of Traditional Chinese Medicine (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05378334 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with EGFR/ALK wild-type non-small cell lung cancer that has spread to bone, who are PD-1 inhibitor–naïve, have ECOG performance status ≤2, and have normal liver and kidney function.

Not a fit: Patients with EGFR or ALK mutations, prior PD-1 inhibitor exposure, poor organ function, poor performance status, or no bone metastases are unlikely to meet entry criteria or benefit from this regimen.

Why it matters

Potential benefit: If successful, adding HGXJT could improve treatment response or reduce bone-related symptoms when given with standard immunotherapy.

How similar studies have performed: High-quality randomized evidence for combining traditional Chinese herbal formulas like HGXJT with immune checkpoint inhibitors in bone-metastatic NSCLC is limited, so this approach is relatively novel and not yet proven.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

• 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

Conditions Non-small Cell Lung Cancer; Non-Small Cell Lung Cancer; Bone Metastatic; Immune Checkpoint Inhibitors; Chinese Formula; Efficacy; Safety