Endostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.

Lung Cancer Clinical Trial

Official title:

A Study of Endostar Combination With Chemotherapy and Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Lung Cancer Rechallenging Treatment After Resistance of EGFR-TKI and Tumor Progression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02350361
• Other study ID #: PekingUTH-LL01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 12, 2015
• Last updated: January 25, 2015
• Start date: January 2014
• Est. completion date: March 2016

Study information

• Verified date: January 2015
• Source: Peking University Third Hospital
• Contact: Li Liang, MD
• Phone: 13241870816
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Here we are going to find a method by using available multiple drugs including angiogenesis medicine - Endostar to treat lung cancer patients who acquired resistence from EGFR-TKI but have responsed to it before.

Description:

Lung cancer patients who received epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKI) will acquiring resistance to the drug. This is a study of using Endostar, an angiogentic medicine, combination with chemotherapy and EGFR-TKI in lung cancer rechallenging treatment after resistance of EGFR-TKI and progression disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with pathologic confirmation of NSCLC with tissue diagnosis or cytologic diagnosis, whose NSCLCs are locally advanced or metastatic Stage III-B / IV adenocarcinoma, and are inoperable and incurable with radiotherapy.

• Life expectancy of at least three (3) months after the start of administration of the investigational drug.

• Eastern Cooperative Oncology Group (ECOG) performance Score 0 to 2.

• Patients with at least one tumor lesion that can accurately be measured by CT or MRI in at least one dimension with longest diameter to be recorded as no less than double the slice thickness and >=10 mm.

• Patient received at least 6 months EGFR-TKI and show tumor progress

• Adequate hematologic hepatic and renal functions based on the normal conditions of chemotherapy

• Patient signed consent form and adherence and geographic location are liable to follow up

Exclusion Criteria:

• CNS metastasis

• Active infection

• Bleeding tendency or blood coagulation dysfunction

• History of neurological or psychiatric disorders, including epilepsy, or dementia

• Pregnancy or breast-feeding women

• Organ transplant long-term use of immunosuppressive drugs

• Arrhythmia need anti-arrhythmic treatment or other risk of heart disease

• Use other targeted drugs during the research

• Other conditions may not allowed to join in this study according to the researcher's judgment

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Recombinant human endostatin
Recombinant human endostatin 7.5mg/m2
• Placebo
Placebo

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Responese Rate		in two months	No
Secondary	Progression Free Survival		up to six months	No
Secondary	Overall Survial		follow up every two months, about two years	No
Secondary	Number of Serious Adverse Events		within two months	Yes