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Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

Primary Purpose

Non-small Cell Lung Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ICI

Chemotherapy

Placebo

Bone-protecting and Mass-dispersesing Decoction

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer, Bone Metastatic, Immune Checkpoint Inhibitors, Chinese Formula, Efficacy, Safety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Guangdong Provincial Hospital of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Combination Group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

(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).

Secondary Outcome Measures

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.

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.

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).

Full Information

NCT ID

NCT05378334

First Posted

April 4, 2022

Last Updated

August 11, 2022

Sponsor

Guangzhou University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05378334

Brief Title

Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 15, 2022 (Actual)

Primary Completion Date

March 1, 2024 (Anticipated)

Study Completion Date

March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangzhou University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combination Group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

ICI

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bone-protecting and Mass-dispersesing Decoction

Intervention Description

Chinese Herbal Formula,also named as HGXJT

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

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.

Title

Overall survival (OS)

Description

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.

Title

ORR(Objective response rate)

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wenjie Zhao, Dr

Phone

8602081887233

Ext

34830

20209120019@stu.gzucm.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haibo Zhang, Professor

Organizational Affiliation

Guangdong Provincial Hospital of Traditional Chinese Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangdong Provincial Hospital of Traditional Chinese Medicine

City

Guangzhou

State/Province

Guangdong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haibo Zhang, Professor

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

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