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

NCT ID: NCT05098990

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2024-08-15

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Jinfukang oral liquid+Platinum-based doublet chemotherapy

The usage cycle of Jinfukang oral liquid will be consistent with platinum-based doublet chemotherapy. Jinfukang oral liquid will be taken at day 5 after chemotherapy, and will be taken continuously 3 times per day and 30 mL per time at least 4 cycles. The usage of platinum-based doublet chemotherapy will be performed following the details described at the "Primary Lung Cancer Diagnosis and Treatment Guidelines" and "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer".

Group Type: EXPERIMENTAL

Jinfukang oral liquid

Intervention Type: DRUG

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

The usage of platinum-based doublet chemotherapy will be performed following the details described at the "Primary Lung Cancer Diagnosis and Treatment Guidelines" and "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer".

Group Type: ACTIVE_COMPARATOR

Platinum-based doublet chemotherapy

Intervention Type: DRUG

Platinum-based doublet chemotherapy as first line therapy has been shown to be efficacious against non-small cell lung cancer.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Jinfukang koufuye; Chemotherapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Chunxue Chen

Role: CONTACT

Phone: 0755-83360999

Email: Chenchunxue3@999.com.cn

Other Identifiers

ICM-JFK-CR01

Identifier Type: -

Identifier Source: org_study_id