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NCT Number: NCT05378334

Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Haibo Zhang, Professor

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Presence of at least one assessable lesion.
  • Signed informed consent, patient willing to accept this regimen, able to adhere to the medication, and good compliance.

Exclusion criteria

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

Treatment and study plan

ICI

Drug

PD-1 inhibitors selected by clinicians based on patients' condition

Chemotherapy

Drug

AP regimen（Pemetrexed 500mg/m2+carboplatin AUC=5,q3w） for non-squamous cancer patientsor or TP regimen（Paclitaxel 175mg/m2+carboplatin AUC=5, or albumin paclitaxel 100mg/m2+carboplatin AUC=5,q3w）for Squamous cancer patients.

Placebo

Drug

The particle size and color are similar to the HGXJT, and the smell and taste are close to the HGXJT, and the bacteria test is qualified

Bone-protecting and Mass-dispersesing Decoction

Drug

Chinese Herbal Formula,also named as HGXJT

Primary outcomes

  1. (Disease control rate assessed by investigators) DCR (CR+PR+SD)

    Time frame: 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.

    DCR (disease control rate) is defined as sum of complete response (CR) rate, partial response (PR) rate and stable disease (SD) rate, according to RECIST v 1.1, based on the chest, abdomen and/or brain CT/MRI evaluation. Patients will undergo a follow-up imaging examination every 3 months, with an additional imaging examination after the first two cycles of treatment (normally 6 weeks).

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 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.

    The time from the date of randomization to the date of disease progression, date of withdraw, or death from any cause, whichever occurs first.

  2. Overall survival (OS)

    Time frame: From date of randomization to the date of withdraw or date of death from any cause, whichever occurs first, assessed up to 120 months.

    The time from the date of randomization to the date of withdraw or date of death from any cause, whichever occurs first.

  3. ORR(Objective response rate)

    Time frame: From date of randomization until the date of death or date of withdraw, whichever came first, assessed up to 120 months

    ORR (overall response rate) is defined as sum of complete response (CR) rate and partial response (PR) rate , according to RECIST v 1.1, based on the chest, abdomen and/or brain CT/MRI evaluation. Patients will undergo a follow-up imaging examination every 3 months, with an additional imaging examination after the first two cycles of treatment (normally 6 weeks).

Study contacts

Contact information is provided by the study sponsor or research team.

Wenjie Zhao, Dr

CONTACT

[email protected]

8602081887233 ext. 34830

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
May 18, 2022
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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