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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

NCT05098990•China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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;
+1 more criteria

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.

Key Dates

Start Date

October 25, 2021

Primary Completion Date

June 15, 2024

Completion Date

August 15, 2024

Last Updated

October 29, 2021

Enrollment

328

ESTIMATED participants

Conditions

Non Small Cell Lung Cancer

Interventions

Jinfukang oral liquid

DRUG

Platinum-based doublet chemotherapy

DRUG

Contacts

Chunxue Chen

CONTACT

0755-83360999 Chenchunxue3@999.com.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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