Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

Guangzhou University of Traditional Chinese Medicine82 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

ICIDRUG

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

ChemotherapyDRUG

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.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

(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

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.

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.

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

Central Contacts

Wenjie Zhao, Dr

CONTACT

8602081887233 20209120019@stu.gzucm.edu.cn

Data from ClinicalTrials.gov

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