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

Phase 2

• Conditions: Lung Cancer
• Interventions: Drug: Placebo; Drug: Recombinant human endostatin

• Registration Number: NCT02350361
• Lead Sponsor: Peking University Third Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2015-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-25
• Last Update Submitted: 2015-01-25
• Study First Posted: 2015-01-29
• Last Update Posted: 2015-01-29
• Primary Completion: 2015-07
• Study Completion: 2016-03

Recruitment & Eligibility

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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Arm	Placebo	Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Placebo
Endostar Arm	Recombinant human endostatin	Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Recombinant human endostatin 15mg/day, day 1 - 14

Primary Outcome Measures

Name	Time	Method
Objective Responese Rate	in two months

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	up to six months
Overall Survial	follow up every two months, about two years
Number of Serious Adverse Events	within two months

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China