Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

Guangzhou University of Traditional Chinese Medicine

Status: Enrolling

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Placebo; Drug: Bone-protecting and Mass-dispersesing Decoction; Drug: ICI; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05378334

2021KT0613

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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82 participants in 2 patient groups, including a placebo group

Combination Group

Experimental group

Description:

Standard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year. HGXJT decoction: 1 dose daily, until tumor progression or accumulation for 1 year.

Treatment:

Drug: Bone-protecting and Mass-dispersesing Decoction

Drug: Chemotherapy

Drug: ICI

Control group

Placebo Comparator group

Description:

Standard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year. Placebo: 1 dose daily, until tumor progression or accumulation for 1 year.

Treatment:

Drug: Chemotherapy

Drug: Placebo

Drug: ICI