Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Endostar -Continued Pumping into+GP; Drug: Endostar -injecting into +GP

• Registration Number: NCT01669707
• Lead Sponsor: Beijing Chest Hospital

Brief Summary

The purpose of this study is to determine whether Endostar pumping into vein with Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly in the treatment of Non-Small Cell Lung Cancer (NSCLC).

Detailed Description

Endostar have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued vein-pumping Combining with Gemcitabine-Cisplatin (GP)chemotherapy in patients with NSCLC,and seeking for more effective injection.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-21
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Histologically or cytologically diagnosed NSCLC;

2. primary treatment,inoperable stage IIIB/IV NSCLC;

3. Age of 18-75years; Gender Not Required;

4. Adequate hematologic, renal, and hepatic function ,Specific index as follows:

   liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l, Hb≥100 g/l;

5. ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;

6. The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);

7. No history of serious drug allergy;

8. Informed consent should be obtained before treatment.

Exclusion Criteria

1. Symptomatic brain metastases with cognitive disorder,bone metastases with complications;
2. Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);
3. Serious complications and investigator consider it is unsuited enrolling;
4. Pregnant or lactating women;
5. Allergic to research drug;
6. participating in other experimental trials and receive the treatment in four weeks;
7. The position that is for observing curative effect have a radiotherapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endostar -Continued Pumping into+GP	Endostar -Continued Pumping into+GP	Endostar that is Continued Pumping into vein Combining With Gemcitabine -Cisplatin
Endostar -injecting into +GP	Endostar -injecting into +GP	Endostar that is injecting into vein with Gemcitabine -Cisplatin

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	two years

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	two years
Clinical benefit rate (CBR)	two years
Number of Participants With Adverse Events(AE) as a Measure of Safety and Tolerability	two years

Trial Locations

Locations (1)

The Beijing Chest Hospital; 🇨🇳 Beijing, China