A Study of Ginsenoside H Dripping Pills for Advanced Non-Small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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Ginsenoside H dripping pills is a kind of traditional Chinese medicine(TCM), This study is being conducted to evaluate the efficacy and safety of ginsenoside H dripping pills in patients with advanced (stage ⅢB/Ⅳ) Non-small Cell Lung Cancer (Syndrome Of Qi-Deficiency) and explore the optimal dosage

Official Title
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A PhaseⅡa, Placebo Parallel Control, Central Randomized, Double Blind, Dosage Exploring and Multi-Center Study to Evaluate the Efficacy and Safety of Ginsenoside H Dripping Pills in Patients With Advanced NSCLC (Syndrome Of Qi-Deficiency)

Conditions
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Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Drug: Ginsenoside H dripping pills
* Drug: Ginsenoside H dripping pills+Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically or cytologically proven stage IIIB/IV NSCLC with a measurable lesions (including postoperative recurrence or metastasis) The patients who can not be treated by surgical resection, conventional radiotherapy and chemotherapy or molecular targeted drugs treatment failure, not willing to accept, or intolerance to radiotherapy and chemotherapy or molecular targeted therapy. The TCM Syndrome diagnosis of Qi-Deficiency. Aged 18-75 years, both male and female. ECOG performance status 0-2. Expected to survive more than 3 months. Joined in the test voluntarily and signed the Informed consent by GCP regulation. Exclusion Criteria: Liver and kidney damage(TBIL、ALT、AST is higher than the limit of normal value of 1.5 times, abnormal Cr). Patients with significant cachexia. Untreated symptomatic brain metastases. 4 .Allergic constitution, or for a variety of drug allergy. 5 .Combined with severe cardiovascular, hepatic, renal disease , pregnancy or breast-feeding women, psychopath. 6. Participated in other clinical trial within 3 months. 7. Treated by chemotherapy, radiotherapy or targeted therapy within 4 weeks. 8. Possible to be treated by chemotherapy, radiotherapy or targeted therapy during the study. 9. Not fit for the clinical trial judged by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginsenoside H dripping pills<br>Drug: Ginsenoside H dripping pills. Dosage form:pill. Dosage :20pills ( only ginsenoside H dripping pills). Frequency:two times per day. Duration: until disease progression or death. | Drug: Ginsenoside H dripping pills<br>* Experimental: Ginsenoside H dripping pills. Dosage form:pill. Dosage :20pills ( only ginsenoside H dripping pills). Frequency:two times per day. Duration: until disease progression or death.<br>|
| Experimental: Ginsenoside H dripping pills+Placebo<br>Drug: Ginsenoside H dripping pills ,Placebo. Dosage form:pill. Dosage :20pills ( ginsenoside H dripping pills 10 pills and placebo 10 pills). Frequency:two times per day. Duration: until disease progression or death. | Drug: Ginsenoside H dripping pills+Placebo<br>* Experimental: Drug: Ginsenoside H dripping pills+Placebo. Dosage form:pill. Dosage :20pills ( ginsenoside H dripping pills 10 pills and placebo 10 pills). Frequency:two times per day. Duration: until disease progression or death.<br>|
| Placebo Comparator: Placebo<br>Drug: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death. | Drug: Placebo<br>* Placebo Comparator: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Evaluate progression free survival (PFS) in the 3 groups : 0 , every 8 weeks and the end of treatment | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Evaluate overall survival (OS) in the 3 groups | through study completion, an average of 1 year | 
| Time to progression(TTP) | Evaluate time to progression(TTP) in the 3 groups | through study completion, an average of 1 year | 
| Quality of Life | [0 , every 4 weeks and the end of treatment] To determine the quality of life by using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scales. | through study completion, an average of 1 year | 
| Symptoms scores of TCM | 0 , every 4 weeks and the end of treatment | through study completion, an average of 1 year | 
| Cancer-related fatigue | Evaluate the fatigue degree in the 3 groups using the Chinese version of Brief Fatigue Index (BFI-C): 0 , every 4 weeks and the end of treatment | through study completion, an average of 1 year |