Clinical trial NCT05098990: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non Small Cell Lung Cancer
Lead sponsor: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to 18 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 18 months
measure: Objective Response Rate (ORR)
timeFrame: Up to 18 months
measure: Disease Control Rate (DCR)
timeFrame: Up to 18 months
measure: Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
timeFrame: Up to 18 months
measure: Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 (EORTC QLQ-LC13)
timeFrame: Up to 18 months
measure: Incidence and Severity of Adverse Events (AE)
timeFrame: Up to 18 months
measure: Incidence and Severity of Serious Adverse Event (SAE)
timeFrame: Up to 18 months
measure: Incidence and severity of Adverse Drug Reactions (ADR)，Serious Adverse Drug Reactions (SADR) or Suspected Unexpected Serious Adverse Drug Reactions (SUSAR)
timeFrame: Up to 18 months
measure: Change from baseline of peripheral immune cell counts
timeFrame: Up to 18 months
Other outcomes:
measure: Circulating tumor DNA (ctDNA) level measurement
timeFrame: Up to 18 months
Locations:
Study officials:
References: