This trial is active, not recruiting.

Condition cancer
Treatments jinfukang, xingzaoruanjian, pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin
Phase phase 2/phase 3
Sponsor Shanghai University of Traditional Chinese Medicine
Collaborator Shanghai Chest Hospital
Start date September 2014
End date December 2016
Trial size 120 participants
Trial identifier NCT02777788, ZY3-CCCX-3-3023


The purpose of this study is to observe the efficacy of chemotherapy combined with Chinese patent drugs for patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
(Active Comparator)
Eligible subjects will be treated with platinum-doublet 2 cycles chemotherapy:pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin. Each cycle was 21-days. Dosage:pemetrexed i.v.500mg/m2 d1 ; docetaxel i.v.75mg/m2 d1 ; gemcitabine i.v.1250 mg/m2 d1,d8 ; paclitaxel i.v.175mg/m2 d1 ; vinorelbine i.v.25mg/m2 d1,d8; carboplatin i.v.area under curve (AUC) 5 d1 ;cis-platinum i.v.75mg/m2 d1(or divided into 3days);nedaplatin i.v.80mg/m2 d1.
pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin
TCM:JinFuKang plus XingZaoRuanJian, chemotherapy will be the same. JinFuKang po.tid.30ml d6-d21 XingZaoRuanJian po.tid.30ml d6-d21
jinfukang JinFuKang oral liquid
treated with chemotherapy
xingzaoruanjian RuanHuaTang
treated with chemotherapy

Primary Outcomes

Progression-Free Survival
time frame: From date of randomization until the date of first documented progression or date of death from any cause,up to 2 months

Secondary Outcomes

Objective response rate
time frame: up to 2 months
time frame: up to 2 months
Number of participants with treatment-related quality of life as assessed by FACT-L4.0
time frame: 21 days

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: 1. Pathologically or cytologically confirmed of stage Ⅲb-Ⅳ NSCLC 2. Ages Eligible for Study: 18-65 years old; 3. Physical status score (ECOG PS) ≤ 2 scores; 4. Estimated life expectancy of at least 6 months; 5. Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥10g/dL, absolute neutrophil count (ANC) ≥1.5*109/L, platelets ≥80*109/L, Liver and kidney function is normal; 6. Informed consent from the patient. Exclusion Criteria: 1. Patient with other malignant tumor except NSCLC 5 years previous to study entry. 2. Patients who have received targeted drug treatment; 3. Serious problem of heart, liver or kidney with severe dysfunction; 4. Pregnant or child breast feeding women; 5. Mental or cognitive disorders; 6. Participating in other drug trials; 7. Who are allergic to the study drug. 8. Diabetic patients.

Additional Information

Official title Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan
Description Lung cancer is the most common malignant tumor in the world with about 80%-85% non small cell lung cancer. The investigators perform a multi-center, randomized, controlled, prospective study in patients with advanced NSCLC. Patients are randomized over observational group(Chinese patent drugs plus chemotherapy), and control group (chemotherapy). The investigators will observe 2 cycles and after that regular follow-up will be arranged. The primary end point is: Objective response rate; The secondary end points are: 1. progression-free survival(PFS); 2. overall survival(OS); 3. Time to Progression (TTP); 4. quality of life questionnaire(QOL); 5. other end points are: Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect that integrated TCM combined with chemotherapy has a better efficacy on enhancing Objective response rate,prolonging PFS, OS, improving QOL, reducing the adverse reaction of patients than that of chemotherapy.Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Shanghai University of Traditional Chinese Medicine.