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Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

NCT05378334 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-03-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ICI

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

DRUG

Chemotherapy

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.

DRUG

Placebo

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

DRUG

Bone-protecting and Mass-dispersesing Decoction

Chinese Herbal Formula,also named as HGXJT

Sponsors & Collaborators

  • Guangzhou University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Haibo Zhang, Professor · Guangdong Provincial Hospital of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2027-09-01
Completion
2028-01-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378334 on ClinicalTrials.gov