Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT02195453 |
Recruitment Status : Unknown
Verified July 2014 by Jinming Yu, Shandong Cancer Hospital and Institute.
Recruitment status was: Not yet recruiting
First Posted : July 21, 2014
Last Update Posted : July 21, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Lung Cancer | Drug: Yangzhengxiaoji Capsule Drug: Placebo Capsule | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 520 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized,Double-blind,Placebo-Controlled,Multicenter Clinical Trail of Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer |
Study Start Date : | August 2014 |
Estimated Primary Completion Date : | September 2016 |
Estimated Study Completion Date : | December 2016 |

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. |
- Functional Assessment of Cancer Therapy-Lung scale [ Time Frame: 84day ]
- Lung Cancer Symptom Scale [ Time Frame: 84day ]
- Anti-cancer drugs common grading evaluation of adverse reaction [ Time Frame: 84day ]
- Completion of chemotherapy [ Time Frame: 84 day ]
- Objective response rate [ Time Frame: 84day ]
- Progression-free survival [ Time Frame: 84 day ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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;
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195453
Contact: Ligang Xing, M.D. | 18053100188 | xinglg@gmail.com |
Study Chair: | Jinming Yu, PhD | Shandong Cancer Hospital and Institute | |
Study Chair: | Jie Wang, PhD | Biejing Cancer Hospital |
Responsible Party: | Jinming Yu, Shandong Cancer Hospital and Institute |
ClinicalTrials.gov Identifier: | NCT02195453 |
Other Study ID Numbers: |
yl-yxb08-lcsyfa-201302 |
First Posted: | July 21, 2014 Key Record Dates |
Last Update Posted: | July 21, 2014 |
Last Verified: | July 2014 |
Non-small cell lung cancer FACT-L scale Yangzhengxiaoji |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |