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Jinfukang Oral Liquid Combined With Chemotherapy for Treating Driver Gene-negative Advanced NSCLC

Primary Purpose

Non Small Cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Jinfukang oral liquid
Platinum-based doublet chemotherapy
Sponsored by
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-80 years of age;
  2. Patients with stage ⅢB-IV NSCLC are diagnosed by histopathology and cytology;
  3. Patients' tumor tissues are unresectable as assessed by the investigator;
  4. Have measurable disease based on RECIST 1.1;
  5. Driver gene (EGFR/ALK/ROS1) is negative;
  6. Patients who are receiving first-line platinum-doublet chemotherapy with remaining no fewer than 4 therapeutic cycles;
  7. Patients in chemotherapy who combined with other systemic therapy (including but not limited to immune checkpoint inhibitors and anti-vascular targeted drugs) are not suitable, but with radiotherapy can be permitted;
  8. During chemotherapy cycles, patients who take prior treatment with anticancer Chinese medicine less than 4 weeks can be enrolled after stopping medication. If administration time is longer than 4 weeks, at least 4 weeks washout period should be performed;
  9. Patients are diagnosed with Qi-yin deficiency by the Syndrome Differentiation of Traditional Chinese Medicine;
  10. The expected survival time ≥3 months;
  11. The subjects volunteer to sign the informed consent.

Exclusion Criteria:

  1. Allergy or hypersensitivity to ingredients of the study treatment formulation;
  2. Pregnant or lactating women;
  3. Patients with multiple brain metastases, multiple bone metastases and liver metastases, which have great influence on survival times;
  4. Patients are enrolling in other therapeutic trials;
  5. The investigator does not consider the participant to be eligible for this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Jinfukang oral liquid+Platinum-based doublet chemotherapy

    Platinum-based doublet chemotherapy

    Arm Description

    The usage cycle of Jinfukang oral liquid will be consistent with platinum-based doublet chemotherapy. Jinfukang oral liquid will be taken at day 5 after chemotherapy, and will be taken continuously 3 times per day and 30 mL per time at least 4 cycles. The usage of platinum-based doublet chemotherapy will be performed following the details described at the "Primary Lung Cancer Diagnosis and Treatment Guidelines" and "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer".

    The usage of platinum-based doublet chemotherapy will be performed following the details described at the "Primary Lung Cancer Diagnosis and Treatment Guidelines" and "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer".

    Outcomes

    Primary Outcome Measures

    Progression Free Survival (PFS)
    Time from the start of treatment to first progression disease or death, whichever is earlier, according to RECIST 1.1 criteria.

    Secondary Outcome Measures

    Overall Survival (OS)
    Time from randomization to death from any cause, according to RECIST 1.1 criteria.
    Objective Response Rate (ORR)
    ORR is defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), according to RECIST 1.1 criteria.
    Disease Control Rate (DCR)
    Disease control rate is defined as the proportion of patients with complete response (CR) or partial response (PR) or subjects with stable disease (SD), according to RECIST 1.1 criteria.
    Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
    30 quality of life questions for the participant to answer. The first 28 questions have answers that range from 1 (Not at All) to 4 (Very Much), and the final 2 questions answers range from 1 (Very Poor) to 7 (Excellent).
    Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 (EORTC QLQ-LC13)
    13 quality of life questions for the participant to answer. The answers range from 1 (Not at All) to 4 (Very Much).
    Incidence and Severity of Adverse Events (AE)
    An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment.
    Incidence and Severity of Serious Adverse Event (SAE)
    SAE refers to events that require hospitalization, prolong hospitalization, disability, impact on work ability, life-threatening or death, and congenital malformations that occur during clinical trials.
    Incidence and severity of Adverse Drug Reactions (ADR),Serious Adverse Drug Reactions (SADR) or Suspected Unexpected Serious Adverse Drug Reactions (SUSAR)
    ADR: All noxious and unintended responses to a medicinal product related to any dose. SUSAR: all suspected adverse.
    Change from baseline of peripheral immune cell counts
    Surface expression of CD3, CD4 and CD8 is assessed as a marker of absolute T lymphocyte, T helper cell and cytotoxic T lymphocyte, respectively.

    Full Information

    First Posted
    September 21, 2021
    Last Updated
    October 17, 2021
    Sponsor
    China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05098990
    Brief Title
    Jinfukang Oral Liquid Combined With Chemotherapy for Treating Driver Gene-negative Advanced NSCLC
    Official Title
    A Prospective, Randomized, Multicenter Real-world Study of Jinfukang Oral Liquid Combined With Chemotherapy in Treatment for Patients With Driver Gene-negative Advanced Non-small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 25, 2021 (Anticipated)
    Primary Completion Date
    June 15, 2024 (Anticipated)
    Study Completion Date
    August 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a prospective, randomized, multicenter real-world study, which aims to investigate the efficacy and safety of Jinfukang oral liquid combined with chemotherapy as first-line treatment regimen for patients with driver-negative advanced NSCLC. 328 patients with unresectable stage IIIB-IV NSCLC and Qi-Yin deficiency will be divided into experimental (n=164) and control groups (n=164) according to the stratified blocked randomization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non Small Cell Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    328 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Jinfukang oral liquid+Platinum-based doublet chemotherapy
    Arm Type
    Experimental
    Arm Description
    The usage cycle of Jinfukang oral liquid will be consistent with platinum-based doublet chemotherapy. Jinfukang oral liquid will be taken at day 5 after chemotherapy, and will be taken continuously 3 times per day and 30 mL per time at least 4 cycles. The usage of platinum-based doublet chemotherapy will be performed following the details described at the "Primary Lung Cancer Diagnosis and Treatment Guidelines" and "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer".
    Arm Title
    Platinum-based doublet chemotherapy
    Arm Type
    Active Comparator
    Arm Description
    The usage of platinum-based doublet chemotherapy will be performed following the details described at the "Primary Lung Cancer Diagnosis and Treatment Guidelines" and "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer".
    Intervention Type
    Drug
    Intervention Name(s)
    Jinfukang oral liquid
    Other Intervention Name(s)
    Jinfukang koufuye
    Intervention Description
    Jinfukang koufuye is a Chinese herbal prescription, which is used in treatment for patients with NSCLC in clinical practice. It has been proved to be capable of preventing the occurrence of metastasis, stabilizing tumor lesions, improving the response rates when combined with chemotherapy, and prolonging the survival period of lung cancer patients.
    Intervention Type
    Drug
    Intervention Name(s)
    Platinum-based doublet chemotherapy
    Other Intervention Name(s)
    Chemotherapy
    Intervention Description
    Platinum-based doublet chemotherapy as first line therapy has been shown to be efficacious against non-small cell lung cancer.
    Primary Outcome Measure Information:
    Title
    Progression Free Survival (PFS)
    Description
    Time from the start of treatment to first progression disease or death, whichever is earlier, according to RECIST 1.1 criteria.
    Time Frame
    Up to 18 months
    Secondary Outcome Measure Information:
    Title
    Overall Survival (OS)
    Description
    Time from randomization to death from any cause, according to RECIST 1.1 criteria.
    Time Frame
    Up to 18 months
    Title
    Objective Response Rate (ORR)
    Description
    ORR is defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), according to RECIST 1.1 criteria.
    Time Frame
    Up to 18 months
    Title
    Disease Control Rate (DCR)
    Description
    Disease control rate is defined as the proportion of patients with complete response (CR) or partial response (PR) or subjects with stable disease (SD), according to RECIST 1.1 criteria.
    Time Frame
    Up to 18 months
    Title
    Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
    Description
    30 quality of life questions for the participant to answer. The first 28 questions have answers that range from 1 (Not at All) to 4 (Very Much), and the final 2 questions answers range from 1 (Very Poor) to 7 (Excellent).
    Time Frame
    Up to 18 months
    Title
    Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 (EORTC QLQ-LC13)
    Description
    13 quality of life questions for the participant to answer. The answers range from 1 (Not at All) to 4 (Very Much).
    Time Frame
    Up to 18 months
    Title
    Incidence and Severity of Adverse Events (AE)
    Description
    An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment.
    Time Frame
    Up to 18 months
    Title
    Incidence and Severity of Serious Adverse Event (SAE)
    Description
    SAE refers to events that require hospitalization, prolong hospitalization, disability, impact on work ability, life-threatening or death, and congenital malformations that occur during clinical trials.
    Time Frame
    Up to 18 months
    Title
    Incidence and severity of Adverse Drug Reactions (ADR),Serious Adverse Drug Reactions (SADR) or Suspected Unexpected Serious Adverse Drug Reactions (SUSAR)
    Description
    ADR: All noxious and unintended responses to a medicinal product related to any dose. SUSAR: all suspected adverse.
    Time Frame
    Up to 18 months
    Title
    Change from baseline of peripheral immune cell counts
    Description
    Surface expression of CD3, CD4 and CD8 is assessed as a marker of absolute T lymphocyte, T helper cell and cytotoxic T lymphocyte, respectively.
    Time Frame
    Up to 18 months
    Other Pre-specified Outcome Measures:
    Title
    Circulating tumor DNA (ctDNA) level measurement
    Description
    Blood sample will be collected for ctDNA testing.
    Time Frame
    Up to 18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-80 years of age; Patients with stage ⅢB-IV NSCLC are diagnosed by histopathology and cytology; Patients' tumor tissues are unresectable as assessed by the investigator; Have measurable disease based on RECIST 1.1; Driver gene (EGFR/ALK/ROS1) is negative; Patients who are receiving first-line platinum-doublet chemotherapy with remaining no fewer than 4 therapeutic cycles; Patients in chemotherapy who combined with other systemic therapy (including but not limited to immune checkpoint inhibitors and anti-vascular targeted drugs) are not suitable, but with radiotherapy can be permitted; During chemotherapy cycles, patients who take prior treatment with anticancer Chinese medicine less than 4 weeks can be enrolled after stopping medication. If administration time is longer than 4 weeks, at least 4 weeks washout period should be performed; Patients are diagnosed with Qi-yin deficiency by the Syndrome Differentiation of Traditional Chinese Medicine; The expected survival time ≥3 months; The subjects volunteer to sign the informed consent. Exclusion Criteria: Allergy or hypersensitivity to ingredients of the study treatment formulation; Pregnant or lactating women; Patients with multiple brain metastases, multiple bone metastases and liver metastases, which have great influence on survival times; Patients are enrolling in other therapeutic trials; The investigator does not consider the participant to be eligible for this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chunxue Chen
    Phone
    0755-83360999
    Email
    Chenchunxue3@999.com.cn

    12. IPD Sharing Statement

    Learn more about this trial

    Jinfukang Oral Liquid Combined With Chemotherapy for Treating Driver Gene-negative Advanced NSCLC

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