Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

NCT05378334 | Recruiting

• 1 other identifier: 2021KT0613
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

Non-small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Bone Metastatic; Immune Checkpoint Inhibitors; Chinese Formula; Efficacy; Safety

Outcome Measures

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).

  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 (3)

• Progression-free survival (PFS)

  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)

  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)

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

Study Arms (2)

Combination Group

EXPERIMENTAL

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; Drug: Chemotherapy; Drug: Bone-protecting and Mass-dispersesing Decoction

Control group

PLACEBO COMPARATOR

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; Drug: Chemotherapy; Drug: Placebo

Interventions

Bone-protecting and Mass-dispersesing Decoction DRUG

Chinese Herbal Formula,also named as HGXJT

Combination Group

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.

Combination Group; Control group

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

Control group

ICI DRUG

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

Combination Group; Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

RECRUITING

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Haibo Zhang, Professor

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjie Zhao, Dr

CONTACT

8602081887233; 20209120019@stu.gzucm.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: May 18, 2022
• Study Start: June 15, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 10, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)