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

NCT05098990 | Unknown Phase 4

• 1 other identifier: ICM-JFK-CR01
• Study Type: interventional
• Target: 328
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Overall Survival (OS)

  Up to 18 months

• Objective Response Rate (ORR)

  Up to 18 months

• Disease Control Rate (DCR)

  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)

  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)

  Up to 18 months

Other Outcomes (1)

• Circulating tumor DNA (ctDNA) level measurement

  Up to 18 months

Study Arms (2)

Jinfukang oral liquid+Platinum-based doublet chemotherapy

EXPERIMENTAL

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

Platinum-based doublet chemotherapy

ACTIVE COMPARATOR

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

Interventions

Jinfukang oral liquid 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.

Also known as: Jinfukang koufuye

Jinfukang oral liquid+Platinum-based doublet chemotherapy

Platinum-based doublet chemotherapy DRUG

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

Also known as: Chemotherapy

Platinum-based doublet chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age;
• Patients with stage ⅢB-IV NSCLC are diagnosed by histopathology and cytology;
• Patients' tumor tissues are unresectable as assessed by the investigator;
• Have measurable disease based on RECIST 1.1;
• Driver gene (EGFR/ALK/ROS1) is negative;
• Patients who are receiving first-line platinum-doublet chemotherapy with remaining no fewer than 4 therapeutic cycles;
• 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;
• 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;
• Patients are diagnosed with Qi-yin deficiency by the Syndrome Differentiation of Traditional Chinese Medicine;
• The expected survival time ≥3 months;
• The subjects volunteer to sign the informed consent.

You may not qualify if:

• Allergy or hypersensitivity to ingredients of the study treatment formulation;
• Pregnant or lactating women;
• Patients with multiple brain metastases, multiple bone metastases and liver metastases, which have great influence on survival times；
• Patients are enrolling in other therapeutic trials;
• The investigator does not consider the participant to be eligible for this study.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Chunxue Chen

CONTACT

0755-83360999; Chenchunxue3@999.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 29, 2021
• Study Start: October 25, 2021
• Primary Completion: June 15, 2024
• Study Completion: August 15, 2024
• Last Updated: October 29, 2021

Record last verified: 2021-10