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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
328
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 chemotherapy as first line therapy has been shown to be efficacious against non-small cell lung cancer.
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.
Time frame: Up to 18 months
Overall Survival (OS)
Time from randomization to death from any cause, according to RECIST 1.1 criteria.
Time frame: 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.
Time frame: 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.
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)
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
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).
Time frame: Up to 18 months
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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.
Time frame: 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.
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)
ADR: All noxious and unintended responses to a medicinal product related to any dose. SUSAR: all suspected adverse.
Time frame: 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.
Time frame: Up to 18 months