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

• Status: Not yet recruiting
• Trial end date: 2024-08-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

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.