Clinical trial NCT05378334: Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients
Official title: Efficacy and Safety of Bone-protecting and Mass-dispersesing Decoction (HuGuXiaoJiTang, HGXJT) Combining With ICIs in Bone Metastatic NSCLC Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Bone Metastatic
Immune Checkpoint Inhibitors
Chinese Formula
Efficacy
Safety
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomized controlled study evaluating the efficacy and safety of HGXJT in combination with ICI-based standard treatment in lung cancer patients with bone metastases. Enrolled participates will randomly receive HGXJT or placebo during the first 4-6 cycles of ICI-based standard treatment.


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.

Primary outcomes:
measure: (Disease control rate assessed by investigators) DCR (CR+PR+SD)
timeFrame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
measure: Overall survival (OS)
timeFrame: From date of randomization to the date of withdraw or date of death from any cause, whichever occurs first, assessed up to 120 months.
measure: ORR(Objective response rate)
timeFrame: From date of randomization until the date of death or date of withdraw, whichever came first, assessed up to 120 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Haibo Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
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