Non Small Cell Lung CancerPhase 4NCT05098990
Jinfukang Oral Liquid Combined With Chemotherapy for Treating Driver Gene-negative Advanced NSCLC
A Phase 4 study testing Jinfukang oral liquid and Platinum-based doublet chemotherapy in people with Non Small Cell Lung Cancer, run by China Resources Sanjiu Medical & Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Jinfukang oral liquid and Platinum-based doublet chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2021to 15 Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Jinfukang oral liquid, Platinum-based doublet chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jinfukang oral liquidDrug
Also called Jinfukang koufuye
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.
Platinum-based doublet chemotherapyDrug
Also called Chemotherapy
Platinum-based doublet chemotherapy as first line therapy has been shown to be efficacious against non-small cell lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| Jinfukang oral liquid+Platinum-based doublet chemotherapy | Experimental | 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". Receives: Drug: Jinfukang oral liquid |
| Platinum-based doublet chemotherapy | Active comparator | 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". Receives: Drug: Platinum-based doublet chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 18 months
Secondary outcomes (9)
Overall Survival (OS)
Time from randomization to death from any cause, according to RECIST 1.1 criteria.
Measured: Up to 18 months
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.
Measured: Up to 18 months
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.
Measured: Up to 18 months
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).
Measured: Up to 18 months
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).
Measured: Up to 18 months
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.
Measured: Up to 18 months
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.
Measured: Up to 18 months
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.
Measured: Up to 18 months
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.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start25 Oct 2021 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098990
- Sponsor's protocol ID
- ICM-JFK-CR01
- Status last verified
- Oct 2021
- First submitted
- 21 Sep 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05098990
- Acronym / sponsor ID
- ICM-JFK-CR01
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2021 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jinfukang oral liquid+Platinum-based doublet chemotherapy | Experimental | Drug: Jinfukang oral liquidThe 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". |
| Platinum-based doublet chemotherapy | Active comparator | Drug: Platinum-based doublet chemotherapyThe 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". |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jinfukang oral liquidAlso: Jinfukang koufuyeJinfukang 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. | Drug | Jinfukang oral liquid+Platinum-based doublet chemotherapy |
| Platinum-based doublet chemotherapyAlso: ChemotherapyPlatinum-based doublet chemotherapy as first line therapy has been shown to be efficacious against non-small cell lung cancer. | Drug | Platinum-based doublet chemotherapy |
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to 18 months
Time from the start of treatment to first progression disease or death, whichever is earlier, according to RECIST 1.1 criteria.
9 secondary outcomes
Overall Survival (OS)
Time frame: Up to 18 months
Objective Response Rate (ORR)
Time frame: Up to 18 months
Disease Control Rate (DCR)
Time frame: Up to 18 months
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
Time frame: Up to 18 months
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 (EORTC QLQ-LC13)
Time frame: Up to 18 months
Incidence and Severity of Adverse Events (AE)
Time frame: Up to 18 months
Incidence and Severity of Serious Adverse Event (SAE)
Time frame: Up to 18 months
Incidence and severity of Adverse Drug Reactions (ADR)，Serious Adverse Drug Reactions (SADR) or Suspected Unexpected Serious Adverse Drug Reactions (SUSAR)
Time frame: Up to 18 months
Change from baseline of peripheral immune cell counts
Time frame: Up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Jinfukang oral liquid and Platinum-based doublet chemotherapy in people with Non Small Cell Lung Cancer, run by China Resources Sanjiu Medical & Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunxue Chen (0755-83360999, Chenchunxue3@999.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.