Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: ICI
* Drug: Chemotherapy
* Drug: Placebo
* Drug: Bone-protecting and Mass-dispersesing Decoction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination Group<br>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. | Drug: ICI<br>* PD-1 inhibitors selected by clinicians based on patients' condition<br>Drug: Chemotherapy<br>* 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.<br>Drug: Bone-protecting and Mass-dispersesing Decoction<br>* Chinese Herbal Formula,also named as HGXJT<br>|
| Placebo Comparator: Control group<br>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. | Drug: ICI<br>* PD-1 inhibitors selected by clinicians based on patients' condition<br>Drug: Chemotherapy<br>* 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.<br>Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (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). | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 
| 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. | From date of randomization to the date of withdraw or date of death from any cause, whichever occurs first, assessed up to 120 months. | 
| 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). | From date of randomization until the date of death or date of withdraw, whichever came first, assessed up to 120 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Small Cell Lung Cancer, Bone Metastatic, Immune Checkpoint Inhibitors, Chinese Formula, Efficacy, Safety