NCT05098990

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Jinfukang oral liquid	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.
DRUG	Platinum-based doublet chemotherapy	Platinum-based doublet chemotherapy as first line therapy has been shown to be efficacious against non-small cell lung cancer.

Timeline

• Start date: 2021-10-25
• Primary completion: 2024-06-15
• Completion: 2024-08-15
• First posted: 2021-10-29
• Last updated: 2021-10-29