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Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangzhou University of Traditional Chinese Medicine

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Combination GroupExperimental treatment 3 interventions
Group B: Control groupPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

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).

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.

Secondary outcomes

1

Progression-free survival (PFS)

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

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.
2

Overall survival (OS)

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

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.
3

ORR(Objective response rate)

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).

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou University of Traditional Chinese Medicine

Lead sponsor

Source ClinicalTrials.gov
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