Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to observe quality of life and treatment side effects in patients with advanced non small cell lung cancer (NSCLC) receive chemotherapy and Yangzhengxiaoji capsule.

Official Title
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A Randomized,Double-blind,Placebo-Controlled,Multicenter Clinical Trail of Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Yangzhengxiaoji Capsule
* Drug: Placebo Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Histology and/or cytology confirmed stage Ⅳ NSCLC patients; With at least one measurable solid tumor (RECIST standard version 1.1): tumor >=10 mm in diameter on CT or MRI images, or lymph node >=15 mm in diameter on CT or MRI images; Eastern Cooperative Oncology Group(ECOG) score 0-1, expectant survival > 3 months; Age: 18-70 years; Normal organ function: Bone marrow: neutrophils (ANC) count>=1.5×10^9/L, Platelets count>=100×10^9/L, hemoglobin>=90g/L；Renal function, serum creatinine<=1.5 mg/dl, and/or creatinine clearance or>=60 ml/min; Liver function: total serum bilirubin levels <= 1.5 times the upper limit of normal (ULN), serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT)<=2.5 times the ULN, if abnormal liver function caused by the underlying malignancy, the AST and ALT >=5 times ULN; For patients with brain metastases, bone metastases or pleural effusion, systemic chemotherapy is proposed after the effective local treatment to control symptoms; Informed consent. Exclusion criteria: Clinically significant hepatic dysfunction: AST or ALT > 2.5 times the ULN, total serum bilirubin levels > 1.5 times the ULN; clinically significant renal insufficiency: serum creatinine > 1.5 times the ULN; Severe heart disease: New York Heart Association class Ⅲ-IV class of heart failure, unstable angina, myocardial infarction, coronary revascularization six months before randomization; Spleen resection or combined with other severe hematopoietic system diseases; Uncontrolled diabetes, hypertension (above 180/120mmHg), infection or severe gastrointestinal ulcers; History or present with other cancer, except for non melanoma skin cancer, cervical cancer in situ and other cured cancer for at least 5 years; Mental illness, without legal capacity or limited capacity; Pregnancy, lactation or patients with pregnancy plan; Participated in other clinical trail in the past 1 months or participating in other trail now; Other unsuitable condition decided by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yangzhengxiaoji Capsule<br>Gemcitabine or Pemetrexed Cisplatin Yangzhengxiaoji Capsule four granules t.i.d po | Drug: Yangzhengxiaoji Capsule<br>* Gemcitabine 1000mg/m² or Pemetrexed 500mg/m² IV drip on D1 and D8,21 days for a cycle. Cisplatin 75mg/m² IV drip for one day or two-three days total injection,21 days for a cycle. Yangzhengxiaoji Capsule four granules t.i.d po.<br>|
| Placebo Comparator: Placebo Capsule<br>Gemcitabine or Pemetrexed Cisplatin Placebo Capsule four granules t.i.d po | Drug: Placebo Capsule<br>* Gemcitabine 1000mg/m² or Pemetrexed 500mg/m²IV drip on D1 and D8,21 days for a cycle. Cisplatin 75mg/m² IV drip for one day or two-three days total injection, 21 days for a cycle. Placebo Capsule four granules t.i.d po.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy-Lung scale |  | 84day | 
| Lung Cancer Symptom Scale |  | 84day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-cancer drugs common grading evaluation of adverse reaction |  | 84day | 
| Completion of chemotherapy |  | 84 day | 
| Objective response rate |  | 84day | 
| Progression-free survival |  | 84 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small cell lung cancer, FACT-L scale, Yangzhengxiaoji