Curative Study of Chinese Traditional Medicine to Treat Lung Cancer

Phase 2

• Conditions: Cancer
• Interventions: Drug: pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin; Drug: JinFuKang; Drug: XingZaoRuanJian

• Registration Number: NCT02777788
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-19
• Status Verified: 2017-05
• Last Update Submitted: 2017-10-06
• Last Update Posted: 2017-10-10
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chemotherapy	pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin	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.
TCM combined chemotherapy	JinFuKang	TCM：JinFuKang plus XingZaoRuanJian, chemotherapy will be the same. JinFuKang po.tid.30ml d6-d21 XingZaoRuanJian po.tid.30ml d6-d21
TCM combined chemotherapy	XingZaoRuanJian	TCM：JinFuKang plus XingZaoRuanJian, chemotherapy will be the same. JinFuKang po.tid.30ml d6-d21 XingZaoRuanJian po.tid.30ml d6-d21

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	From date of randomization until the date of first documented progression or date of death from any cause，up to 2 months	The progression disease is assessed based on CT every 2 months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer.

Secondary Outcome Measures

Name	Time	Method
Time-to-Progression	up to 2 months
Number of participants with treatment-related quality of life as assessed by FACT-L4.0	21 days
Objective response rate	up to 2 months