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

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

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.

Study Overview

• Status: Unknown
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Yangzhengxiaoji Capsule; Drug: Placebo Capsule

• Study Type: Interventional
• Enrollment (Anticipated): 520
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ligang Xing, M.D.; Phone Number: 18053100188; Email: xinglg@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Histology and/or cytology confirmed stage Ⅳ NSCLC patients;
2. 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;
3. Eastern Cooperative Oncology Group(ECOG) score 0-1, expectant survival > 3 months;
4. Age: 18-70 years;

5. 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;

6. For patients with brain metastases, bone metastases or pleural effusion, systemic chemotherapy is proposed after the effective local treatment to control symptoms;
7. Informed consent.

Exclusion criteria:

1. 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;
2. Severe heart disease: New York Heart Association class Ⅲ-IV class of heart failure, unstable angina, myocardial infarction, coronary revascularization six months before randomization;
3. Spleen resection or combined with other severe hematopoietic system diseases;
4. Uncontrolled diabetes, hypertension (above 180/120mmHg), infection or severe gastrointestinal ulcers;
5. 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;
6. Mental illness, without legal capacity or limited capacity;
7. Pregnancy, lactation or patients with pregnancy plan;
8. Participated in other clinical trail in the past 1 months or participating in other trail now;
9. Other unsuitable condition decided by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yangzhengxiaoji Capsule; Gemcitabine or Pemetrexed Cisplatin Yangzhengxiaoji Capsule four granules t.i.d po	Drug: Yangzhengxiaoji Capsule; 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.
Placebo Comparator: Placebo Capsule; Gemcitabine or Pemetrexed Cisplatin Placebo Capsule four granules t.i.d po	Drug: Placebo Capsule; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute
• Collaborators: Peking University Cancer Hospital & Institute
• Investigators: Study Chair: Jinming Yu, PhD, Shandong Cancer Hospital and Institute; Study Chair: Jie Wang, PhD, Biejing Cancer Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 7, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Estimate): July 21, 2014
• Last Update Submitted That Met QC Criteria: July 17, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer; FACT-L scale; Yangzhengxiaoji
• 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: yl-yxb08-lcsyfa-201302