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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Jinfukang oral liquid; Drug: Platinum-based doublet chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 328
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Chunxue Chen; Phone Number: 0755-83360999; Email: Chenchunxue3@999.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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".	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.; Other Names: Jinfukang koufuye
Active Comparator: 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".	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.; Other Names: Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	Time from the start of treatment to first progression disease or death, whichever is earlier, according to RECIST 1.1 criteria.	Up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time from randomization to death from any cause, according to RECIST 1.1 criteria.	Up to 18 months
Objective Response Rate (ORR)	ORR is defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), according to RECIST 1.1 criteria.	Up to 18 months
Disease Control Rate (DCR)	Disease control rate is defined as the proportion of patients with complete response (CR) or partial response (PR) or subjects with stable disease (SD), according to RECIST 1.1 criteria.	Up to 18 months
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)	30 quality of life questions for the participant to answer. The first 28 questions have answers that range from 1 (Not at All) to 4 (Very Much), and the final 2 questions answers range from 1 (Very Poor) to 7 (Excellent).	Up to 18 months
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 (EORTC QLQ-LC13)	13 quality of life questions for the participant to answer. The answers range from 1 (Not at All) to 4 (Very Much).	Up to 18 months
Incidence and Severity of Adverse Events (AE)	An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment.	Up to 18 months
Incidence and Severity of Serious Adverse Event (SAE)	SAE refers to events that require hospitalization, prolong hospitalization, disability, impact on work ability, life-threatening or death, and congenital malformations that occur during clinical trials.	Up to 18 months
Incidence and severity of Adverse Drug Reactions (ADR)，Serious Adverse Drug Reactions (SADR) or Suspected Unexpected Serious Adverse Drug Reactions (SUSAR)	ADR: All noxious and unintended responses to a medicinal product related to any dose. SUSAR: all suspected adverse.	Up to 18 months
Change from baseline of peripheral immune cell counts	Surface expression of CD3, CD4 and CD8 is assessed as a marker of absolute T lymphocyte, T helper cell and cytotoxic T lymphocyte, respectively.	Up to 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating tumor DNA (ctDNA) level measurement	Blood sample will be collected for ctDNA testing.	Up to 18 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): October 25, 2021
• Primary Completion (Anticipated): June 15, 2024
• Study Completion (Anticipated): August 15, 2024

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: October 17, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 17, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ICM-JFK-CR01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No